Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term
Management of Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term; the Mode of Delivery and the Neonatal Outcomes
1 other identifier
observational
324
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies complicated with isolated oligohydramnios managed by induction of labor. This prospective case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women with postdate pregnancies who met the inclusion criteria underwent induction of labor with dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared between two groups.
Trial Health
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participants targeted
Target at P75+ for all trials
Started Jan 2013
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedOctober 21, 2015
January 1, 2013
1.4 years
October 13, 2015
October 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cesarean rates in pregnancies complicated with isolated oligohydramnios
up to 18 month
Secondary Outcomes (3)
Fetal distress rates
up to 18 month
Number of patients (fetus) with 5-min Apgar score < 7
up to 18 month
Number of patients with meconium stained amniotic fluid
up to 18 month
Study Arms (2)
term isolated oligohydramnios
Labor Monitoring and normal delivery tracking
prolonged pregnancies
Labor Monitoring and normal delivery tracking
Interventions
normal delivery tracking
Eligibility Criteria
All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to accurate last menstrual period and first trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index \< 5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of last menstrual period and first trimester ultrasound.
You may qualify if:
- term isolated oligohydramnios
- postdate pregnancies
- vertex presentation
- singleton pregnancies
- primigravid and multigravid women
You may not qualify if:
- women with presence of any chronic disease
- maternal condition complicating the pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 21, 2015
Study Start
January 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
October 21, 2015
Record last verified: 2013-01