NCT03789903

Brief Summary

AF lactate level could help in predicting the duration from ROM till delivery

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

December 26, 2018

Last Update Submit

December 27, 2018

Conditions

Rupture of Membranes; Premature

Outcome Measures

Primary Outcomes (1)

  • latency period

    duration from ROM till the occurrence of active labor

    upto 48 hours

Interventions

amniotic fluid lactateDIAGNOSTIC_TEST

AF lactate

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with PPROM
  • GA between 24 to 34 weeks

You may not qualify if:

  • chorioamnionitis
  • previous Preterm labor
  • abruptio placentae
  • UTI ,pyelonephritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Abbassya, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Radwa R Ali, MD

CONTACT

01283492979radwaebed@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2018

First Posted

December 31, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

December 31, 2018

Record last verified: 2018-12

Locations

EG(1)