Trials Sponsors Conditions Drugs Pricing

Conditions

Duration of Labor

Outcome Measures

Primary Outcomes (1)

length of the second stage of labor
the length of the second stage of labor starting from full cervical dilatation till delivery of the fetus will be recorded.
1 hour

Study Arms (2)

obstetric gel group

EXPERIMENTAL

they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel.

Drug: obsteric gel(k-Y jelly)

no intervention group

NO INTERVENTION

they will receive the standard care during labor and delivery without the use of the obstetrical gel

Interventions

obsteric gel(k-Y jelly)Drug

A sterile obstetric gel( K-Y Jelly 82GM; manufactured by Johnson\& Johnson) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that have purely physical activity. Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child manually or using the sterile obstetric gel applicator without any manipulation or massage.

obstetric gel group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 40 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age between 18 and 40 years
Women who have had only one prior cesarean birth with no previous vaginal delivery, are eligible for VBAC and plan to attempt a VBAC after counseling.

Sponsors & Collaborators

Cairo University
Otherlead

Study Sites (1)

Ahmed Ashour

Giza, 12944, Egypt

Study Officials

AHMED SAMY, MD
Cairo University
PRINCIPAL INVESTIGATOR

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: lecturer in obstetrics and gynecology

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 23, 2018

Study Start

December 30, 2018

Actual (reported)

Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

obstetric gel group

no intervention group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

obstetric gel group

no intervention group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations