Early Versus Delayed Pushing in the Second Stage of Labor

November 2, 2018 updated by: Ahmed Maged, Cairo University
Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.

Oxytocin was allowed in both group and fetus was monitored with CTG.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Kasr Alainy Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women
  • Gestational age 36 to 40 weeks
  • singleton pregnancy

Exclusion Criteria:

  • women indicated for cesarean section
  • Medical complications of pregnancy as hypertensive disorders or Diabetes Mellitus
  • Fetal distress
  • Epidural anaesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early pushing during vaginal delivery
patients are allowed to push within one hour after full cervical dilatation whether the vertex was visible or not
Procedure: vaginal delivery
vaginal delivery is carried by an expert obstetrician and the need for forceps or ventose is recorded
Active Comparator: Delayed pushingduring vaginal delivery
patients here are asked not to push for maximum of 3 hours or start pushing when the vertex was visible
Procedure: vaginal delivery
vaginal delivery is carried by an expert obstetrician and the need for forceps or ventose is recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
successful vaginal delivery
Time Frame: within 3 hours from full cervical dilatation
success of vaginal delivery
within 3 hours from full cervical dilatation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

September 25, 2018

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaginal Delivery

Clinical Trials on vaginal delivery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe