About the Dianatal® Obstetric gel
Dianatal® is sterile obstetric gel that has unique biophysical properties which allow it to ease the process of vaginal birth. The gel applies a mucoadhesive film onto the birth canal; thus reducing friction between the vagina and the baby, and allowing the baby to slide out. This procedure was discovered by the Swiss obstetrician Dr. Schaub from Zurich, Switzerland in 2002. Initial studies at the Swiss Federal Technology Institute indicated that the use of the specially developed Obstetric Gel reduced various levels of friction by over 50%. Data from subsequent clinical trials in different obstetric centers demonstrate that the duration of the delivery can be considerably shortened.
Dianatal® obstetric gel does not contain any pharmaceutically active ingredients. Dianatal® obstetric gel is sterile and filled in sterile single-use tubes and packed in single use sterile bags. Dianatal® obstetric gel is an odourless, almost colourless gel. Dinatal is highly viscous, with a slightly acidic pH and electric conductive.
Dianatal® is:
- Sterile, and packaged in sterile single-use tubes
- Odorless, almost colorless, and highly viscous
- Bioadhesive
- Electroconductive (conductivity above 5 mS. cm-1)
- Slightly acidic (pH of 5.5 – 6.5)
- Free of latex, phthalate, and preservatives
- Non-pyrogenic
- Non-allergenic
- Kind on mucus membranes and the eyes
Dianatal® contains:
- Propylene glycol
- Natrosol 250M
- Carbopol 974P NF
- Sodium chloride
- Sodium hydroxide
- Purified water
Dianatal® Obstetric gel has purely physical effects. It contains no pharmaceutical active ingredients and is not absorbed by the body. Intensive tests have been carried out to assess the tolerance and safety for mother and child (vaginal tissue, skin, eyes, nose and mouth). The main biophysical active ingredient is Carbopol 974P NF
The process of childbirth is divided into two stages. The uterine cervix opens during the first stage, the dilation stage. When the cervix is fully dilated (10 cm), the so-called expulsion stage (second stage) starts. During the expulsion stage, the vaginal tissue or the perineum may tear spontaneously. This occurs in approximately 45% of all births. However, it is not always possible to prevent tearing even with doing episiotomy. The research has strongly demonstrated that the incidence of perineal tearing was reduced significantly when Dianatal® Obstetric Gel was used.
Dianatal® obstetric gel is applied after each vaginal examination during the entire delivery process after the onset of regular contractions, starting optimally with the vaginal examination around 3-4 cm dilatation of the cervix (active phase). Dianatal® obstetric gel should be used throughout the entire labour. Approx. 3-5 ml of Dianatal® obstetric gel per application is applied with the tube or manually to the presenting part. The application of Dianatal® obstetric gel is consecutively performed in a 1 to 2 hours interval to ensure an optimal lubrication film on the birth canal to make delivery safer & easier for mother and baby. Application is best performed directly after vaginal examination. In very dry vaginal conditions ~ 2 ml fluid should be added after the gel is applied. An additional application of gel should be made 15-30 minutes after rupture of the amniotic sac. Dianatal® can be applied manually or by inserting the tube into the vagina. Do use a dry towel to deliver the baby to prevent slipping.
In nulliparous women, Dianatal® Obstetric Gel was found to shorten the expulsion stage by 30% (26 min.) and shorten the total duration of the birth by 30% (106 min.)(2, 3) Dianatal® also aids and eases deliveries for which a vacuum cup or forceps are used.
Dianatal®, therefore, makes childbirth safer, faster and less painful. The unborn child and the vagina, pelvic floor and perineum of the mother are protected.
Dianatal® therefore makes childbirth safer, faster and less painful. The unborn child and the vagina,
pelvic floor and perineum of the mother are protected.
Dianatal® obstetric gel - key benefits:
reducing trauma & saving time and pain
- Developed to ease childbirth for mother and baby
- Clinically proven for safety, effectiveness, and tolerability for mother & baby (RCT results)
- Reduces duration of labour Stage II (RCT results)
- Reduces incidence of perineal damage and protects the vagina (RCT results)
Childbirth today: the Dutch experience
- Dutch mothers are relatively old when their first child is born: 29.4 years of age.
- The proportion of home births is around 30%.
- In 2005, 51 % of nulliparae and 17 % of multiparae who intended to give birth at home were admitted during parturition.
- Some of the reasons include nonprogressive dilation or expulsion and exhaustion of the mother.
- 23 % of Dutch primiparae have negative memories of the birth experience three years later
- Compared with women who gave birth spontaneously, 42 % and 47 % respectively of women who experienced a vaginaloperative delivery and an unplanned C-section, look back on the birth experience with dissatisfaction.
- Ruptures and/or episiotomies, especially with nulliparae, are associated with the risk of sexual dysfunction, painful perineum or incontinence after the birth. Recent data show that an episiotomy also bears a significantly greater risk of a second-degree rupture or worse in a subsequent birth..
- The duration of the expulsion stage, low parity and vaginal-operative birth are independent risk factors for an increased chance of vaginal and perineal ruptures.
Indications and use of Dianatal® Obstetric gel
Dianatal® Obstetric gel has been developed especially for the facilitation of vaginal child birth. It is highly bioadhesive and has a high water-binding capacity. Dianatal® Obstetric gel is used during a vaginal birth to make the birth faster and easier for both mother and child and to protect the pelvic floor and the perineum.
Method of application: Only intended for local application in the vaginal birth canal.
As Dianatal® Obstetric gel conducts electricity, diathermy for haemostasis can be carried out at any time after the use of Dianatal® – for example, for a C-section or for revision of the birth canal. In order to guarantee conductivity only use Dianatal® for birth facilitation.
Side effects: No side effects have been reported to date.
Contraindications: Dianatal® Obstetric gel may not be used:
- there is the possibility of an allergic reaction to any of the ingredients
- vaginal delivery is contra-indicated
References:
- Riener R, Leypold K, Brunschweiler A, Schaub A, Bleul U, Wolf P. Quantification of friction force reduction induced by obstetric gels. Medical & biological engineering & computing. 2009;47(6):61723.
- Seval MM, Yuce T, Yakistiran B, Sukur YE, Ozmen B, Atabekoglu C, et al. Effects of obstetric gel on the process and duration of labour in pregnant women: Randomised controlled trial. Journal of obstetrics and gynecology : the journal of the Institute of Obstetrics and Gynaecology. 2017;37(6):714-8.
- Schaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. Journal of perinatal medicine. 2008;36(2):129-35.
- Bäurle G BS, Hornstein OP, Nürnberg E, Muckenschnabel R. The suitability of propylene glycol (1,2-propanediol) as an active antimicrobial adjuvant in ointments. Z Hautkr. 1985;60(15):1198213.
- Kinnunen T, Koskela M. Antibacterial and antifungal properties of propylene glycol, hexylene glycol, and 1,3-butylene glycol in vitro. Acta Derm Venereol. 1991;71(2):148-50.