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Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes

NCT ID: NCT05559957

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

636 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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)

Conditions

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Oligohydramnios, Delivered

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Isolated oligohydramnios group

Cases with oligohydramnios (amniotic fluid index less than 5) without an overt underlying reason in the third trimester

observation of delivery and neonatal outcomes

Intervention Type BEHAVIORAL

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

observation of delivery and neonatal outcomes

Intervention Type BEHAVIORAL

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

Interventions

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observation of delivery and neonatal outcomes

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hytham Atia

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hytham Atia Atia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Armed Forces Hospitals Southern Region KSA

Locations

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Armed Forces Hospitals Southern Region

Khamis Mushait, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 14961882 (View on PubMed)

Other Identifiers

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AFHSRMREC/2020/OB/GYNAE/429

Identifier Type: -

Identifier Source: org_study_id