HK1113541A - Novel composition for easing human child birth - Google Patents

Description

Novel composition for facilitating childbirth

Description of the invention

The present invention relates to a composition with lubricating effect, which is used especially in human vaginal childbirth.

Vaginal delivery of an infant is a complex process and is determined by three basic factors: birthing (fetus, amnion, placenta), birth canal (consisting of bone parts and soft tissue tract), and labor strength. Various delivery forces (geburkskiften) are known from the specialist scientific literature, which promote or inhibit vaginal delivery of human fetuses. In this connection, the labor promoting forces are contractions and gravity, while the labor inhibiting forces are the tension of the uterine orifice and birth canal. Delivery of a human infant is divided into 3 stages: open phase, labor phase and post-labor phase. The duration of normal childbirth for the primiparous woman averages 12 hours, while the duration of normal childbirth for the menstruation woman averages 8 hours. The reason for the shorter mean delivery duration of the parturient compared to the primiparous woman is the reduced tension of the birth canal, as the parturient's soft tissue tract [ internal soft tissue tract (uterus segment-cervical canal-soft tissue accessory canal (vagina and vulva)) ] becomes thinner through the previous vaginal delivery. Therefore, the main theories about human labor mechanics are: the tension of the birth canal (the force required to open, stretch and thin the canal) is considered to be an important labor deterrent (Dudenhausen, Schneider, Frauenheilkunded Gebutshilfe, Verlag De Gruyter (1994), p. 113-.

In veterinary medicine, the mechanical significance of labor of friction between the birthing and birth canal has been known for decades. Application of lubricants to the birth canal to reduce friction is a standard method in veterinary obstetrics (Richter, G ö tze; tiergeurtshilfe, 4 th edition; Verlag PaulParey; Rechtsfragen in der tiergeurtshilfe, page 614) and lubricants for this purpose are commercially available. In animal parturition, relatively large lubricant doses may be used. Aqueous preparations of liquids can thus be used, which are used in useful animals as a substitute for the lubricating amniotic or allantoic fluid. Such large amounts are not possible to use in vaginal childbirth in humans due to lack of practicality.

One fundamental difference between the delivery of animals and humans is: the effect of amniotic fluid at human term delivery is not significantly related to lubricating the birth canal and may instead increase the resulting friction. Amniotic fluid (as a water-containing substance) has no significant lubricating effect in humans by itself. Currently, in humans, vaginal childbirth is mostly performed only in the head position, where the discharge of amniotic fluid during childbirth is considered to be insignificant due to blockage of the head. The majority of vernix (the sole lubricating substance of the birthing) is no longer present around the expected date of delivery and has little effect on the head anyway. Thus, the use of amniotic fluid or amniotic fluid substitute to lubricate the birth canal prior to or during vaginal delivery in humans is not a sufficiently suitable method for reducing friction and facilitating vaginal delivery in humans.

Us patent 3814797 discloses aqueous lubricating compositions based on (a) potassium metaphosphate, (B) alginic acid, carboxymethylcellulose, carboxymethyl starch and salts thereof, and (C) sodium salts of weak acids, such as sodium carbonate or sodium phosphate.

Us patent 3971848 discloses a lubricant composition for mucous membranes containing a mixture of fucoidan and alginate. The composition may optionally be mixed with carboxymethylcellulose, sodium polyacrylate, sodium potassium polyphosphate, polyethylene oxide, etc., and used to ease labor.

Us patent 4267168 discloses a liquid biocidal composition which can be used as a cleanser, surface disinfectant or vaginal lubricant. The composition comprises lauryl diethanolamide, propylene glycol, glycerin, sodium polypectate and silver ions. Its pH value is 7.2-7.8.

JP 46024256 discloses a lubricant composition consisting essentially of a polyacrylate salt and useful as an accelerating uterine fluid in veterinary medicine.

JP 45000153 and JP 4500012 disclose a lubricant composition for use in veterinary medicine for promoting labour comprising a salt or ester of alginic acid and acacia gum.

JP 46034991 discloses a lubricant composition comprising polyethylene oxide powder in a liquid consisting of an organic solvent at a concentration > 80%, hydroxypropyl cellulose, sodium sulphate and a detergent. In veterinary medicine, the composition may be used after dilution to facilitate fetal removal.

PCT/EP03/00548 discloses the use of physiologically non-problematic organic substances for the preparation of compositions which do not contain alkali metal salts of metaphosphoric acid, said compositions being useful as lubricants in vaginal childbirth in women. Many examples of suitable physiologically non-problematic organic substances are mentioned. The aim of the invention is to reduce the recently recognized, important, labour-hindering forces, i.e. the friction between the birthing and the birth canal, by using a lubricant in humans.

It is an object of the present invention to provide a composition for facilitating childbirth in a human, which composition is physiologically compatible and has good adhesive properties and a lubricating effect.

This object is achieved by a bioadhesive (bioadhadive) composition with lubricating effect, comprising (a) polyacrylic acid, (b) a water-soluble thickener and (c) a humectant and (d) optionally water.

Component (a) of the composition of the present invention is polyacrylic acid, which may be crosslinked or/and chemically modified, or a salt of such polyacrylic acid, or a mixture of polyacrylic acids. The average molecular weight of the acrylic polymers is selected such that they have bioadhesive properties in the intended application. The molecular weight is generally at least 2000D, preferably up to 500000D.

Preferred polyacrylic acids are crosslinked acrylic acid polymers, such as acrylic acid homopolymers, copolymers or interpolymers (interpolymeres) or salts of such polymers, such as alkali or alkaline earth metal salts. Examples of such include carbomer homopolymers, i.e. high molecular weight polymers of acrylic acid crosslinked with polyalkenyl ethers of sugars or polyols (e.g. allyl sucrose, allyl pentaerythritol, etc.), e.g. carbopol^®940NF, 974NF or 980 NF.

In addition, carbomer copolymers are also suitable, i.e.acrylic acid and methacrylic acid C crosslinked with polyalkenyl ethers of sugars or polyols₁-C₂₄High molecular weight copolymers of alkyl esters, e.g. carbopol^®1382. Carbopol^®1342NF, carbopol^®ETD-2020、Pemulen^®TR1 NF and Pemulen^®TR2 NF. Also suitable are carbomer interpolymers, i.e., polymers containing a heterogeneous polymer (e.g., polyethylene glycol and a long chain such as C)₁-C₂₄Block copolymers of alkyl acid esters) of carbomer homopolymers or copolymers, e.g. carbopol^®Ultrez 10, 20 or 21 or carbopol^®Ultrez 10 NF. Also suitable are polycarbophils, i.e. polyacrylic acids crosslinked with divinyl glycol (Divinylglycol), e.g. Noveon^®AA-1USP, or calcium polycarbophil, i.e. calcium salts of polyacrylic acids crosslinked with divinyl glycol, e.g. Noveon^®CA-1USP and CA-2 USP.

Polyacrylic acid homopolymers typically have a COOH group content of 56-68%, while polyacrylic acid copolymers have a COOH group content of 52-62%.

The weight proportion of component (a) in the total weight of the composition may vary within wide limits, for example from 0.1 to 15%. In particular when the composition is present as an aqueous gel, the proportion by weight of component (a) is preferably from 0.1 to 10%, particularly preferably from 0.2 to 1%, very particularly preferably from 0.4 to 0.7%. The weight proportion is most preferably 0.45 to 0.5%.

Component (b) of the composition is a water-soluble thickener or a mixture of thickeners. Preferred examples are cellulose derivatives, in particular hydrophilically modified cellulose derivatives, such as hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose or/and hydroxypropylmethylcellulose. Other preferred water-soluble thickeners are mucopolysaccharides, especially hyaluronic acid.

Component (b) is generally present in a weight proportion of from 0.1 to 30%, preferably from 1 to 10%, particularly preferably from 2.5 to 7.5%, most preferably from 4 to 6%, based on the total weight of the composition.

Component (c) of the composition is a humectant or a mixture of humectants. Preferred examples are pharmaceutically compatible polyols, such as propylene glycol, in particular 1, 2-propylene glycol, glycerol or/and polyethylene glycol, in particular liquid polyethylene glycol.

Component (c) is generally present in a proportion by weight of from 0.1 to 30%, preferably from 10 to 30%, particularly preferably from 15 to 25%, most preferably from 18 to 22%, based on the total weight of the composition.

An optional component (d) of the composition is water. In aqueous compositions, water is generally present in a proportion by weight of from 40 to 95%, preferably from 60 to 85%, particularly preferably from 70 to 80%, most preferably from 72 to 77% by weight of the total composition. Optionally, however, the composition may also be present and used in a form having a relatively low water content or dried (e.g. as a powder), or/and diluted shortly before use.

In addition to the above-mentioned components, the compositions may contain adjuvants, such as surfactants, dispersants, other thickeners, agents for adjusting the pH, carriers, fillers, stabilizers or/and preservatives. However, the composition is preferably preservative-free. Furthermore, it is preferred that the composition be free of alginic acid or alginates, as the addition of these materials often results in the formation of undesirable discoloration or precipitation. Likewise, the composition is preferably free of metaphosphates or/and heavy metal ions, especially silver ions. Preferably, the composition further comprises ethylenediaminetetraacetic acid (EDTA) or/and pharmaceutically acceptable salts thereof.

However, the composition preferably comprises an agent for adjusting the osmolality to be substantially isotonic, for example a salt, such as sodium chloride, in a proportion by weight which is generally from 0.1 to 5%, preferably from 0.3 to 0.6%, particularly preferably from 0.45 to 0.55%, most preferably from about 0.49 to 0.50%, based on the total weight of the composition.

The composition of the invention is preferably a gel, which is advantageously in a substantially colourless and transparent form. Furthermore, the compositions may also be in the form of solid dosage forms such as tablets, powders, pastes, suppositories (Ovuli), dragees, effervescent tablets or suspensions thereof, or in the form of foams. The pH of the composition is preferably adjusted to 4 to 7, particularly preferably 5 to 6, most preferably 5.5 to 6 by adding suitable agents, for example acids such as HCl or bases such as NaOH. In this respect, the determination of the pH is preferably carried out with 1.0% KNO₃The dilution in solution on a 1: 9 gel was carried out by potentiometry.

The viscosity of the composition is preferably from 1 to 40 pas, particularly preferably from 10 to 18 pas. In this connection, the determination of the viscosity is preferably carried out at 20 ℃ using a rotational viscometer (Drehzahlreihe N, class 4, sensor SV DIN, time 60 seconds, 20 revolutions). Alternatively, the viscosity measurement is performed using a Brookfield RVT viscometer, wherein the spindle is rotated at a speed of 0.05 to 100 revolutions per minute.

The conductivity of the composition is preferably 4-25mS cm^-1Particularly preferably 8 to 12 mS.cm^-1Wherein the determination is carried out in accordance with DIN 61326/A1/VDE 0843 part 20/A1, using a conductivity meter, for example Kondaktor 702 from Knick.

The composition advantageously has thixotropic or/and structured viscosity (strukturviskose) characteristics, wherein the viscosity decreases under the influence of an increase in shear stress or/and shear rate. Furthermore, the composition preferably has a high initial shear stress or/and pseudoplastic behavior, i.e. the adhesion of the composition decreases under the influence of an increase in the shear load.

The compositions may be presented in sterile form, which may be sterilized, for example, by steam sterilization or/and by radiation, for example, by gamma radiation. However, the compositions may also be used in unsterilised form or/and comprise preservatives or/and biocidal substances.

The preparation of the composition preferably comprises the following steps:

(i) preparing a first mixture consisting of polyacrylic acid (a) and water (d), optionally adjusting the toxicity, for example by adding NaCl, or/and adjusting the pH, for example by adding a base, such as NaOH, wherein the first mixture is preferably in the form of a gel,

(ii) preparing a second mixture consisting of a water-soluble thickener (b), a humectant (c) and water (d), wherein the second mixture is preferably in the form of a gel,

(iii) the two mixtures are combined in a combined manner,

(iv) optionally, homogenizing, and

(v) optionally, sterilization is performed.

The process or the individual steps thereof can vary depending on the galenic form predefined for the composition or depending on the additives which may be present. Thus, for example, water or/and humectant may be at least partially removed or/and added during the process.

The compositions are preferably in the form of dosage units packaged in a volume of from 5 to 500ml, particularly preferably in the form of dosage units packaged in a volume of from 10 to 20 ml. Here, the composition is advantageously in a package such as a jar (Dosen), syringe (e.g., a single use syringe) or tube, or it may be used as a vaginal suppository. In addition, a vaginal applicator may be used. When using jars, the composition may be applied to the birth canal surface using a finger or spatula. A tube or syringe is more suitable from which the composition can be applied by pressure to the surface of the birth canal. The size of the package may be selected such that the amount of composition is sufficient for a single administration. An elongate tube or syringe may be provided which is of a length substantially corresponding to the length of the birth canal and which is fitted at its end with a discharge port for the composition. Suitably, the discharge openings are arranged, for example in the form of circular slits, so that the composition is distributed completely and substantially uniformly over the surface of the birth canal.

The application of the composition to be used according to the invention is simple and very effective when the composition is administered before the onset of regular contractions, in the opening phase or/and in the delivery phase. Administration may be performed one or more times. Administration shortly before or during the opening period may have the following advantages: the tissue in the birth canal is softened, thereby additionally facilitating the delivery. Likewise, the composition may also be used to promote placental exfoliation.

In a preferred embodiment, the composition may additionally comprise one or more pharmaceutically active substances for use as a medicament for certain indications arising during labour, for example for inhibiting labour or promoting labour, for alleviating pain or/and for preventing infection. The amount of the pharmaceutically active substance may be, for example, from 0.0001 to 50% by weight, preferably from 0.01 to 10% by weight, particularly preferably from 0.01 to 5% by weight, based on the total weight of the composition.

Some examples of substances that direct labour are oxytocin, dinoprostone, sulprostone, misoprostol and hyaluronidase.

Some examples of substances that inhibit childbirth are chondroitin sulfate, hexonaraline, fenoterol, magnesium sulfate, atosiban, calcium antagonists, and nitroglycerin.

Some examples of analgesic substances are bupivacaine, lidocaine, mepivacaine, Rapidocain, mepivacaine hydrochloride, Solarcain and lidocaine hydrochloride.

Some examples of anti-infective and biocidal substances are antibacterial or/and antimicrobial or/and antiviral substances, such as quaternary ammonium compounds, chlorhexidine, povidone iodine and iodine, and iodine-containing compounds.

It is particularly advantageous to incorporate antiviral substances such as nucleoside analogues, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors, for example for preventing the transmission of herpes or HIV from the mother to the infant.

Likewise, the incorporation of antibacterial substances, such as chlorhexidine, for example for preventing the transmission of group B streptococcus from the mother to the baby, is particularly advantageous.

It has also proved to be suitable to incorporate lung surfactants (lung surfactants) such as palmityl choline, Lucinactant, berektan, phospholipa palmone suis, perfluorocarbons, which promote the respiratory activity of the neonate after delivery.

The composition is particularly suitable as a lubricant for facilitating vaginal childbirth in humans or/and for promoting placental exfoliation. It may be administered one or more times before or/and after the onset of regular contractions, as desired. Administration is preferably carried out in the birth canal (including the uterine os). Intraamniotic administration is also suitable.

When the walls of the uterine os or/and vagina (birth canal) are covered with a lubricant before or/and during childbirth, the childbirth of a person can be significantly promoted and the duration of the childbirth can even be reduced, especially in the primiparous woman, by using the composition. Here, the friction between the birth canal and the birthing can be significantly reduced not only in the opening phase but also in the delivery phase. In addition, the risk of injury (e.g., thinning of soft tissue accessory tubes, pelvic floor damage, vaginal lacerations, perineal damage, rectal damage, uterine ruptures, blood loss) can be reduced or eliminated, and long-term damage such as urinary incontinence, fecal incontinence, sexual dysfunction, and psychological disorders can be limited or prevented. Furthermore, labor can be relieved by small friction, which can lead to the avoidance or reduction of vaginal surgery or cesarean section. Artificial placental exfoliation is also facilitated by the lubricant of the present invention.

Preferably, the labor gel is removed from the package prior to use while maintaining sterile conditions. The gel is then applied to the birth canal by hand or other aid, one or more times intermittently, during delivery, until the baby's head is present. In this case, the aim is to cover the birth canal as completely as possible with the lubricating gel. After presenting the baby's head, the gel is wiped off the baby's face with a cloth and optionally additionally a suction is applied to the mouth-nose area. Ideally, the entire delivery of the baby is made with the aid of a cloth so that the baby does not slip out of the hand.

After delivery of the infant or/and after delivery of the placental disc, the birth canal is flushed with a sterile aqueous solution, preferably with a mild sterile aqueous salt solution, to dissolve the emollient gel. This may be done during the treatment of the damage to the perineum or birth canal or independently. Optionally, the lubricating gelling agent may additionally be used to facilitate delivery of the placenta or artificial exfoliation of the placenta. In the case of monitoring of the delivery at the hip position, this is done analogously and with corresponding adjustments.

The invention is further illustrated by the following examples:

examples

Formulation examples A

Formulation example 1

Sodium chloride: 4.95mg/g

Propylene glycol: 200.00mg/g

Carbopol^®940： 4.85mg/g

Hydroxyethyl cellulose (Natrosol 250G): 45.00mg/g

Purifying water: 745.20mg/g

Formulation example 2

Sodium chloride: 4.95mg/g

Sodium hydroxide (5N): 2.00mg/g

Propylene glycol: 200.00mg/g

Carbopol^®980NF： 4.85mg/g

Hydroxyethyl cellulose (Natrosol 250G): 45.00mg/g

Purifying water: 743.20mg/g

Formulation example 3

Sodium chloride: 0.495% (m/m)

Propylene glycol: 20.0% (m/m)

Hydroxyethyl cellulose (Natrosol 250M): 2.5% (m/m)

Carbopol^®980NF： 0.485％(m/m)

Sodium hydroxide (5N): 0.85% (m/m)

Purifying water: 75.67% (m/m)

Formulation example 4

Sodium chloride: 4.95mg/g

Propylene glycol: 200.00mg/g

Noveon AA-1USP polycarbophil: 4.85mg/g

Hydroxyethyl cellulose (Natrosol 250G): 45.00mg/g

Purifying water: 745.20mg/g

Formulation example 5

Sodium chloride: 4.95mg/g

Sodium hydroxide (5N): 2.00mg/g

Propylene glycol: 200.00mg/g

Noveon AA-1USP polycarbophil: 4.85mg/g

Hydroxyethyl cellulose (Natrosol 250G): 45.00mg/g

Purifying water: 743.20mg/g

Formulation example 6

Sodium chloride: 0.495% (m/m)

Propylene glycol: 20.0% (m/m)

Hydroxyethyl cellulose (Natrosol 250M): 2.5% (m/m)

Noveon AA-1USP polycarbophil: 4.85mg/g

Sodium hydroxide (5N): 0.85% (m/m)

Purifying water: 75.67% (m/m)

The product of the above example is a clear, odorless, almost colorless, clear and viscous gel having the following characteristics:

pH value: 5.5-6.0

Viscosity: about 10-18Pa · S (rotational viscometer) (Pa · S ═ Pa × S)

Density: 1.032-1.042g/cm³

Conductivity: 8.0-12.0mS cm^-1

Refractive index n_D ²⁰：1.361(1.26-1.46)

Water binding capacity: height of

Mucoadhesiveness: high.

And (3) pH value measurement: the pH value is determined by potentiometry using a suitable pH meter. Here, the concentration will be 1.0% KNO₃A 10% solution of the gelling agent in solution was used for the measurement.

And (3) viscosity measurement: the viscosity is determined by using a rotational viscometer (instrument and measurement parameters: speed series N/class 4/sensor SV DIN/time 60 s/20 rpm). All measurements were performed at 20 ℃.

Density: the density determination is performed by using a pycnometer or using another equally suitable instrument. The calculation is performed according to the following formula:

δ_20℃＝m·0.99703+0.0012(g/cm³)δ

m-the mass of the liquid to be investigated, weighed in air

W-the mass of the same volume of water, weighed in air.

The volumes of both must be measured at 20 ℃.

Conductivity: the electrical conductivity was measured according to DIN 61326A1/VDE0843 part 20/A1 with a conductivity meter.

Preparation examples

10kg were prepared for packaging into 1000 syringes (each syringe containing 10g)

First, 49.5g of sodium chloride was completely dissolved in 500g of water in a homogenizer (Tornado ET 21). 48.5g of polyacrylic acid (carbopol) was then added^®940) And 2000g of water, and mixed with stirring for 5 minutes. Subsequently, while stirring for 10 minutes, so much aqueous 10% NaOH was added to adjust the pH to 5.5-5.6. The gel thus prepared (mixture 1) was stored at room temperature until use.

In a stirred vessel, 450g of hydroxyethylcellulose (hydroxyethylcellulose H300p) was added to 2000g of 1, 3-propanediol and suspended. 4952g of water was placed in the homogenizer, the suspension was added, followed by mixing and homogenization for 10 minutes. The gel-like mixture (mixture 2) was stored overnight (12 hours). The first prepared mixture 1 was added to this mixture 2 and homogenized for 5 minutes.

The resulting gel was slightly opaque and transparent and odorless and had a pH of 5.5-6.0. The viscosity is 16000mPas (measured at 20 ℃ with a rotational viscometer from Haake, model VT500, speed series N, class 4, sensor SV DIN, time 60 seconds, 20 rpm).

The gel was transferred to a sterile filling apparatus and 1000 syringes were filled with 10g of gel. The outlet of the syringe was closed with a cap, which was then sealed in a film and then sterilized at 121 ℃ for 15 minutes to obtain a ready-to-use product.

Application example C

Example 1:

use of a lubricant for facilitating the opening phase and the delivery phase during labor in humans

In a group of 8-bit primiparous women, a lubricant gel within the scope of the present invention was used in accordance with the present invention. For this reason, the lubricating gel is not only used as is commonly used in vaginal examinations; instead, the birth canal is covered manually and intermittently with lubricant.

The quantity of lubricating gel required for this purpose is 10-15 times greater than for vaginal examinations. In this study group, it was determined that: the mean childbirth duration is significantly shorter than established normal, and vaginal childbirth in these women is generally easier than in comparable primiparous women who do not use a lubricant. Overall, the labor trauma is less for both the mother and the baby. Furthermore, in this study group, no vaginal surgery was required to complete labor and no birth canal injury, such as vaginal lacerations, was found.

Example 2:

use of a lubricant for promoting placental exfoliation

In a group of 5 postpartum placental retention patients, lubricants were applied to the arm and in the birth canal of the midwife in order to promote artificial placental exfoliation. It is shown here that artificial placental detachment can be accomplished more easily and more rapidly, and bleeding can thus be reduced.

Biocompatibility testing

Test program

The formulation example 2 of the present invention was tested for biocompatibility based on the following references:

"In Vitro Fertilization and Embroyo Transfer" A Manual of Basic techniques. Ed.: wolf, Don p., New York & London: plenum press, chapter 5: mouse Embryo Culture Bioassay, pp.57-76, 1988.

2.ISO 10993-12，2002，Biological Evaluation of MedicalDevices-Part12：Sample Preparation and Reference Materials。

3.ISO/IEC 17025，2005，General Requirements for theCompetence of Testing and Calibration Laboratories。

In this test, two-cell stage mouse embryos are introduced into wells of a microtiter plate containing either negative control (minimal medium (MEM)), positive control (latex tube) extract or formulation example 2 extract. Each experiment was performed twice, using 10 embryos each, wherein the embryos were kept in an incubator at 37. + -. 1 ℃ for 72. + -.2 hours.

Results

After 72 hours of exposure, no significant reduction in the number of live mouse embryos was observed for the extract of formulation 2 of the invention compared to the negative control, whereas the positive control caused a significant reduction in the number of live mouse embryos. In view of these test results, formulation example 2 of the present invention was classified as non-embryotoxic.

Claims (20)

1. A composition having lubricating effect comprising

(a) The amount of polyacrylic acid,

(b) a water-soluble thickener, and

(c) a humectant, and

(d) optionally, water.

2. Composition according to claim 1, characterized in that component (a) comprises crosslinked or/and chemically modified polyacrylic acid.

3. Composition according to claim 1 or 2, characterized in that component (b) comprises a cellulose derivative, in particular hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose or/and hydroxypropylmethylcellulose, or/and a mucopolysaccharide, in particular hyaluronic acid.

4. A composition according to any of claims 1 to 3, characterized in that component (c) comprises propylene glycol, glycerol or/and polyethylene glycol.

5. Composition according to any one of claims 1 to 4, characterized in that component (a) is present in a proportion by weight of from 0.1 to 15%, preferably from 0.1 to 10%, relative to the total weight of the composition.

6. Composition according to any one of claims 1 to 5, characterized in that component (b) is present in a proportion by weight ranging from 0.1 to 30%, preferably from 1 to 10%, relative to the total weight of the composition.

7. Composition according to any one of claims 1 to 6, characterized in that component (c) is present in a proportion by weight ranging from 0.1 to 30%, preferably from 10 to 30%, relative to the total weight of the composition.

8. Composition according to any one of claims 1 to 7, characterized in that the composition has a pH value of 4 to 7, preferably 5.5 to 6.

9. Composition according to any one of claims 1 to 8, characterized in that the composition has a viscosity of 1 to 40 Pa-s, preferably 10 to 18 Pa-s.

10. Composition according to any one of claims 1 to 9, characterized in that the composition has thixotropic or/and structured viscosity properties.

11. Composition according to any one of claims 1 to 10, characterized in that the composition has 4 to 25 mS-cm^-1Preferably 8 to 12mS cm^-1The electrical conductivity of (1).

12. Composition according to any one of claims 1 to 11, characterized in that the composition has an osmolality which is substantially isotonic.

13. Composition according to any one of claims 1 to 12, characterized in that the composition is sterilized.

14. Composition according to any one of claims 1 to 13, characterized in that it is preservative-free.

15. Composition according to any one of claims 1 to 14, characterized in that it is in the form of a gel, a solid dosage form, a suspension or a foam.

16. Composition according to any one of claims 1 to 15, characterized in that it further comprises at least one pharmaceutically active substance.

17. Use of a composition according to any one of claims 1 to 16 as a lubricant at vaginal delivery in humans.

18. Use according to claim 17, characterized in that the composition is administered one or more times before or/and after the onset of regular contractions.

19. Use according to claim 17 or 18, characterised in that the composition is administered into the birth canal, optionally including the uterine ostium, or/and within the amniotic membrane.

20. Use of the composition of any one of claims 1-16 as a lubricant for promoting placental exfoliation.