NCT02635451

Brief Summary

To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
unknown

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 15, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

December 15, 2015

Last Update Submit

December 17, 2015

Conditions

Preterm Premature Rupture of Membranes

Keywords

vitamin cPreterm Premature Rupture of Membranes

Outcome Measures

Primary Outcomes (1)

  • relation between serum vitamin C concentration and PPROM

    6 months

Study Arms (2)

study group

Study group included 20 pregnant women with PPROM and fulfilled the inclusion and exclusion criteria.

control group

Control group also included 20 pregnant women without PPROM following every recorded case of PPROM and matched for gestational age.

Eligibility Criteria

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

This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital starting from January 2016. This study will include 40 pregnant women between 28-37 weeks were recruited.

You may qualify if:

  • Singleton pregnancies
  • Gestational age between 28-37 weeks
  • Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal

You may not qualify if:

  • Patients with multiple pregnancies
  • Smoker
  • Polyhydramnios
  • Maternal diseases such as: anemia, diabetes, UTI, RTI and vaginal infection
  • History of PPROM in previous pregnancies
  • Evidence of chorioamnionitis in current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Officials

  • Sherif M Habib, MD

    Professor of Obstetric and Gynecology

    STUDY DIRECTOR

Central Study Contacts

Mohamed Hu Mostafa, MD

CONTACT

01003993165magicmostwanted@yahoo.com

Mohamed Hu Mostafa, MD

CONTACT

01003993912magic2mostwanted@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetric and Gynecology

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 18, 2015

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 18, 2015

Record last verified: 2015-12