NCT07067593

Brief Summary

The aim of this work is to review the indications, procedural complications and outcomes of amnioreduction in pregnancies complicated by polyhydramnios.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 6, 2025

Last Update Submit

July 15, 2025

Conditions

Polyhydramnios

Keywords

AmnioreductionPolyhydramnios

Outcome Measures

Primary Outcomes (2)

  • Gestational age at delivery

    Determine Gestational age at delivery in polyhydramnios patients . Increased age is good.

    4 months

  • Rate of PROM

    Number of cases developed PROM

    4 months

Study Arms (2)

Amnioreduction

Conservative

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All pregnant women between 24 to 38 weeks attending Fetal Medicine Unit at Women's health hospital for antenatal care or admitted due to antepartum hemorrhage or for scheduled surgery and meeting the inclusion criteria are counseled to participate in our study after informed consent. sample size will be devided into 2 groups: Group 1 : patients with Amnioreduction Group 2 : patients with conservative management (without amnioreduction)

You may qualify if:

  • Pregnant women 20- 38 weeks
  • Patients with polyhydramnios

You may not qualify if:

  • Lethal fetal anomalies
  • Pre labor rupture of membranes
  • Placental separation
  • Chorioamnionitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Polyhydramnios

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Mohamed Fekry, PhD

CONTACT

0882312388mohamedbeethoven2040@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer obstetric and gynecology, Specialist Urogynecology

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 16, 2025

Study Start

August 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations

EG(1)