Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes

Completed

• Conditions: Oligohydramnios, Delivered
• Interventions: Behavioral: observation of delivery and neonatal outcomes

• Registration Number: NCT05559957
• Lead Sponsor: Zagazig University

Brief Summary

Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome.

Detailed Description

Retrospective study conducted in Armed Forces Hospitals of Southern Region, comparing cases with oligohydramnios (amniotic fluid level index \<5) to normal amniotic fluid cases (amniotic fluid level index ≥ 8). Primary outcomes are the mode of delivery and adverse perinatal outcomes (including mortality, NICU admission, low Apgar score and sepsis)

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-05-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-28
• Study First Posted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 636

Inclusion Criteria

1. Third trimester pregnancy
2. Isolated oligohydramnios

Exclusion Criteria

1. Multiple pregnancy
2. less than 32 weeks
3. medical disorders like DM HPN
4. Fetal jeopardy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Isolated oligohydramnios group	observation of delivery and neonatal outcomes	Cases with oligohydramnios (amniotic fluid index less than 5) without an overt underlying reason in the third trimester
Normal amniotic fluid group	observation of delivery and neonatal outcomes	Normal pregnancy cases with normal amniotic fluid index

Primary Outcome Measures

Name	Time	Method
Delivery mode	through study completion, an average of 1 year	Either vaginal delivery or cesarean section
Composite neonatal outcomes	through study completion, an average of 1 year	Risk of low Apgar score, transient tachypnea of newborn, ICU admission, etc

Secondary Outcome Measures

Name	Time	Method
Induction of labor rate	through study completion, an average of 1 year	Comparing incidence of labor induction between both groups and between gestational age groups

Trial Locations

Locations (1)

Armed Forces Hospitals Southern Region; 🇸🇦 Khamis Mushait, Saudi Arabia