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CompletedNCT05559957Updated Sep 30, 2022

Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes

An observational study in Oligohydramnios, Delivered, sponsored by Zagazig University. Completed at 1 site in Saudi Arabia. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-30.

Sponsored by Zagazig University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
636
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

Read the 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)

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Conditions studied

  • Oligohydramnios, Delivered

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In context

Oligohydramnios

25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.

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Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Third trimester pregnancy
  2. Isolated oligohydramnios

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
636 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • Normal amniotic fluid group

    Normal pregnancy cases with normal amniotic fluid index

    Behavioral: observation of delivery and neonatal outcomes

Interventions

  • Behavioralobservation of delivery and neonatal outcomes

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

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What researchers measure

Primary outcomes

  1. Delivery mode

    Either vaginal delivery or cesarean section

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

  2. Composite neonatal outcomes

    Risk of low Apgar score, transient tachypnea of newborn, ICU admission, etc

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

Secondary outcomes

  1. Induction of labor rate

    Comparing incidence of labor induction between both groups and between gestational age groups

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

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Study locations

1 site
  • Armed Forces Hospitals Southern Region
    Khamis Mushait, 62411, Saudi Arabia
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References and documents

Publications

  • Zhang J, Troendle J, Meikle S, Klebanoff MA, Rayburn WF. Isolated oligohydramnios is not associated with adverse perinatal outcomes. BJOG. 2004 Mar;111(3):220-5. doi: 10.1111/j.1471-0528.2004.00060.x. PubMed 14961882 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05559957
Lead sponsor
Zagazig University
Responsible party
Hytham Atia (Associate professor, Zagazig University) — Principal investigator
First posted
Sep 29, 2022
Start date
Jan 1, 2020
Primary completion
Mar 1, 2022
Completion
May 1, 2022
Last update
Sep 30, 2022

Study contacts

Hytham Atia Atia, M.D.
principal investigator · Armed Forces Hospitals Southern Region KSA

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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