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Completed

NCT Number: NCT05559957

Isolated Oligohydramnios Less Favorable Delivery and 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.

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Key information

Conditions

Oligohydramnios, Delivered Female Urogenital Diseases and Pregnancy Complications Oligohydramnios Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Armed Forces Hospitals Southern Region

Khamis Mushait, 62411, Saudi Arabia

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Third trimester pregnancy
  • Isolated oligohydramnios

Exclusion criteria

  • Multiple pregnancy
  • less than 32 weeks
  • medical disorders like DM HPN
  • Fetal jeopardy

Treatment and study plan

observation of delivery and neonatal outcomes

Behavioral

MONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS

Primary outcomes

  1. Delivery mode

    Time frame: through study completion, an average of 1 year

    Either vaginal delivery or cesarean section

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2022
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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