NCT03121274

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

April 11, 2017

Last Update Submit

November 2, 2018

Conditions

Vaginal Delivery

Outcome Measures

Primary Outcomes (1)

  • successful vaginal delivery

    success of vaginal delivery

    within 3 hours from full cervical dilatation

Study Arms (2)

Early pushing during vaginal delivery

ACTIVE COMPARATOR

patients are allowed to push within one hour after full cervical dilatation whether the vertex was visible or not

Procedure: vaginal delivery

Delayed pushingduring vaginal delivery

ACTIVE COMPARATOR

patients here are asked not to push for maximum of 3 hours or start pushing when the vertex was visible

Procedure: vaginal delivery

Interventions

vaginal deliveryPROCEDURE

vaginal delivery is carried by an expert obstetrician and the need for forceps or ventose is recorded

Delayed pushingduring vaginal deliveryEarly pushing during vaginal delivery

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 20, 2017

Study Start

August 10, 2017

Primary Completion

August 1, 2018

Study Completion

September 25, 2018

Last Updated

November 5, 2018

Record last verified: 2018-11

Locations

EG(1)