NCT03140683

Brief Summary

In recent decades, the percentage of Cesarean section deliveries has dramatically increased in most countries. Concomitantly, the rates of vaginal birth after Cesarean have decreased steadily. The pregnant women with previous Cesarean section face a difficult choice for their next delivery between a trial of labor after Cesarean or repeat caesarean section delivery. The performance of multiple Cesarean section exposes women to greater risks of complications; furthermore, the risk of complications increases with each subsequent Cesarean section. In fact, women with previous Cesarean section are more likely to experience short and long-term maternal complications in future pregnancies, or a trial of labor after Cesarean, with the risk of \[uterine dehiscence, uterine rupture, genitourinary tract damage, hemorrhage and hysterectomy, abnormal placentation (placenta previa and placenta accreta) and difficulties during surgery

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
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 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

1.3 years

First QC Date

May 3, 2017

Last Update Submit

June 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of women with dehisensce scar and Non-stress test abnormalities

    6 hours

Interventions

antepartum fetal monitoring

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study sample will be collected from Women's Health Hospital of Assiut University and Assuit Health Insurance Hospital

You may qualify if:

  • Pregnant full-term 37-42 weeks.
  • Previous one caesarean section

You may not qualify if:

  • Absolute indication of cesarean section in previous and in current pregnancy
  • Pregnant women with Hemoglobin \<9
  • Pregnant women with bleeding tendency
  • Pregnant women with collagen disease
  • Pregnant women with pre-eclampsia and eclampsia
  • Pregnant women with gestational diabetes
  • Multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

RECRUITING

Study Design

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

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 4, 2017

Study Start

June 1, 2017

Primary Completion

September 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