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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03140683
Other study ID # SDCS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date November 2018

Study information

Verified date June 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date November 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

1. Pregnant full-term 37-42 weeks.

2. Previous one caesarean section

Exclusion Criteria:

1. Absolute indication of cesarean section in previous and in current pregnancy

2. Pregnant women with Hemoglobin <9

3. Pregnant women with bleeding tendency

4. Pregnant women with collagen disease

5. Pregnant women with pre-eclampsia and eclampsia

6. Pregnant women with gestational diabetes

7. Multiple pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
non-stress test
antepartum fetal monitoring

Locations

Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of women with dehisensce scar and Non-stress test abnormalities 6 hours
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