None listed
Conditions
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 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
Study design
Eligibility
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