NCT01891149

Brief Summary

This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula. Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula. Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1.5 years

First QC Date

June 25, 2013

Last Update Submit

February 3, 2015

Conditions

Obstetric Fistula

Outcome Measures

Primary Outcomes (1)

  • Cervical length

    baseline

Secondary Outcomes (1)

  • Hormonal levels

    baseline

Study Arms (1)

Malawian women

Malawian women who present for care at the Fistula Care Centre

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

We will be enrolling 100 Malawian women with obstetric fistula and 10 Malawian women without obstetric fistula.

You may qualify if:

  • Presentation to the Fistula Care Centre in Lilongwe for medical evaluation
  • Ability to consent for study participation in Chichewa
  • Female aged 18-45 years
  • Willingness to undergo pelvic ultrasound for assessment of pelvic organs

You may not qualify if:

  • No history of pregnancy
  • History of hysterectomy
  • Current pregnancy or pregnancy within the past six weeks
  • Seriously or terminally ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fistula Care Centre

Lilongwe, Malawi

Location

Study Officials

  • Jeffrey Wilkinson, MD

    University of North Carolina

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 25, 2013

First Posted

July 2, 2013

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

MA(1)