Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes

September 28, 2022 updated by: Hytham Atia, Zagazig University

Isolated Oligohydramnios is Associated With Less Favorable Delivery and Composite Neonatal Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

636

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Khamis Mushait, Saudi Arabia, 62411
        • Armed Forces Hospitals Southern Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women between 32 and 41 weeks with otherwise normal pregnancy. Isolated oligohydramnios group are diagnosed with amniotic fluid index less than 5.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Isolated oligohydramnios group
Cases with oligohydramnios (amniotic fluid index less than 5) without an overt underlying reason in the third trimester
Behavioral: observation of delivery and neonatal outcomes
MONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS
Normal amniotic fluid group
Normal pregnancy cases with normal amniotic fluid index
Behavioral: observation of delivery and neonatal outcomes
MONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction of labor rate
Time Frame: through study completion, an average of 1 year
Comparing incidence of labor induction between both groups and between gestational age groups
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Hytham Atia Atia, M.D., Armed forces hospitals Southern Region KSA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFHSRMREC/2020/OB/GYNAE/429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oligohydramnios, Delivered

Clinical Trials on observation of delivery and neonatal outcomes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe