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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02952807
Other study ID # 2
Secondary ID
Status Completed
Phase Phase 2
First received October 31, 2016
Last updated June 14, 2017
Start date January 2016
Est. completion date February 2017

Study information

Verified date November 2016
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor


Description:

two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date February 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Indication for labour induction Term pregnancy with alive fetus Bishop score less than five

Exclusion Criteria:

- Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina

Study Design


Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
Misoprostol
vaginal Misoprostol Plus Foley Catheter
Device:
Foley Catheter


Locations

Country Name City State
Egypt Zagazig University Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary induction delivery interval (time from starting induction to delivery) safety issue 48hours
Secondary Need of oxytocin for augmentation of labour safety issue 48h
Secondary Number of doses needed to bring on labour safety issue 48h
Secondary Failed induction (failure to elicit contraction after 72 hours) safety issue 72h
Secondary Hyperstimulation syndrome safety issue 24h
Secondary Cesarean section safety issue 72h
Secondary Severe neonatal morbidity or perinatal death safety issue 28 days
Secondary Serious maternal morbidity or maternal death safety issue 42 days
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