NCT06735703

Brief Summary

To investigate incidince of prom with GBS infection and role of prophylaxis against it

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

December 25, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2026

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

December 11, 2024

Last Update Submit

December 11, 2024

Conditions

Premature Rupture of Fetal MembranesGroup B Streptococcal Infection

Outcome Measures

Primary Outcomes (1)

  • Incidince of prom with GBS infection and prophylaxis against it

    Baseline

Study Arms (1)

Pregnant women after 34 wks with PROM

Drug: To provide ampicillin sulbactam to pregnant women with premature rupture of membrane

Interventions

To provide ampicillin sulbactam to pregnant women with premature rupture of membraneDRUG

To provide ampicillin sulbactam tonpregnant women with premature rupture of membrane after 34 wks gestation

Pregnant women after 34 wks with PROM

Eligibility Criteria

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

Pregnant women with prom

You may qualify if:

  • Pregnant women with prom after 34 wks festation

You may not qualify if:

  • Bleeding disorder
  • emergency conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fetal Membranes, Premature RuptureStreptococcal Infections

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Dina Mohamed Kamel

CONTACT

0927923623dinakamel802@gmail.com

Sherif Abdelmeged badran

CONTACT

0927923623

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dina mohamedkamel

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 16, 2024

Study Start

December 25, 2024

Primary Completion

December 9, 2025

Study Completion

January 9, 2026

Last Updated

December 16, 2024

Record last verified: 2024-12