NCT03261765

Brief Summary

The rate of cesarean section deliveries has increased dramatically worldwide in the last decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to 2007 data and is thought to be over 50% at present. The reasons for this include advanced age of primigravida, a wide range of indications, patient requests, the frequency of women with previous cesareans, women's rejections to offers of sterilization, and the common usage of assisted reproductive techniques

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

2 months

First QC Date

August 23, 2017

Last Update Submit

June 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of abdominal adhesions

    30 minutes

Study Arms (2)

Multiple repeat cesarean (four or more)

Other: Assessment of adhesions

Fewer repeat cesarean (two-three)

Other: Assessment of adhesions

Interventions

Modified Nair scoring system

Fewer repeat cesarean (two-three)Multiple repeat cesarean (four or more)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All women with repeated cesarean section

You may qualify if:

  • Women with at least previous one cesarean section.
  • Women accepted to participate in the study.

You may not qualify if:

  • Previous abdominopelvic surgery other than cesarean section.
  • History of Pelvic inflammatory disease.
  • Women refuse to participate in the study.
  • Intrauterine fetal death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

RECRUITING

Central Study Contacts

Ahmed Abbas

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

June 1, 2018

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations