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The effect of obstetric gels on the labor process and duration in pregnant women

The effect of obstetric gels on the labor process and duration in pregnant women

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000469516
Enrollment
200
Registered
2015-05-13
Start date
2014-01-01
Completion date
2015-03-20
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aimed to investigate the effects of the obstetric gels on the labor process, and perineum after vaginal birth in this study. A total of 200 women with singleton low-risk pregnancies in vertex position at term were recruited for the randomized controlled study. All the pregnant women included and received standard antepartum care randomly assigned to either two groups at the first stage of the labor. Pregnant women in group A underwent a standard antepartum care plus vaginal application of the obstetric gel according to the study protocol. Pregnant women in group B, which is control group for the study underwent standard antepartum care without use of any obstetric gel. The obstetric gel was intermittently applied into the vaginal canal with special applicator beginning early first stage of labor (prior to 4 cm cervical dilation) and ended with the delivery of the baby. 3-5 ml of gel were administered and evenly distributed in the vagina every two hours at examination using a sterile glove by obstetric residency trainer (medical doctor) or obstetrician (specialist).

Interventions

All women included to the study received standard routine antepartum care in delivery room. In this context, obstetric residency trainer (medical doctor) or obstetrician (specialist) attended all the vaginal exams, all the application of the obstetric gel, all the deliveries, and episiotomy (selectively) in our institution as an educational university clinic. All the pregnant women examined vaginally at least every hour until to the end of the first stage, and than examination frequency changed

All women included to the study received standard routine antepartum care in delivery room. In this context, obstetric residency trainer (medical doctor) or obstetrician (specialist) attended all the vaginal exams, all the application of the obstetric gel, all the deliveries, and episiotomy (selectively) in our institution as an educational university clinic. All the pregnant women examined vaginally at least every hour until to the end of the first stage, and than examination frequency changed depend on the labor progress in the second stage of the labor. Continue fetal monitorization was performed with tococardiograph until to the delivery. Maternal and fetal parameters were recorded on partograph during labor. All the pregnant women included and received standard antepartum care randomly assigned to either two groups at the first stage of the labor. Pregnant women in group A underwent a standard antepartum care plus vaginal application of the obstetric gel according to the study protocol. A specially designed sterile obstetric gel which has properties of high mucoadhesive activity, high viscosity, electric conductivity and non-allergenic was used for the study (Gynotal Obstetric – Registered Trademark). The obstetric gel is based on cross-linked polyacrylic acid, hydroxyethylcellulose and propylene glycol and is free of preservatives. The obstetric gel was intermittently applied into the vaginal canal with special applicator beginning early first stage of labor (prior to 4 cm cervical dilation) and ended with the delivery of the baby. 3-5 ml of gel were administered and evenly distributed in the vagina every two hours at examination using a sterile glove by obstetric residency trainer (medical doctor) or obstetrician (specialist). Only one box containing 2 pieces syringes (12ml) labeled as “Stage A” and 1 piece syringe (12ml) labeled as “Stage B” was used for during delivery and limited for each patient. Syringes labeled as “Stage A” and syringe labeled as “Stage B” were performed for the active phase of first stage, and the second stage of labor, respectively. No perineal massage was performed.

Sponsors

Turkuaz Saglik Hizmetleri, Medikal, Temizlik, Kimyasal Urunler San. ve Tic. Ltd. St.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Singleton baby in vertex presentation * Low risk pregnancy * Normoweight fetus (clinically or by sonography) * Term pregnancy

Exclusion criteria

* Indication for cesarean delivery * Macrosomia * Contraindication for vaginal delivery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026