Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula

NCT ID: NCT01891149

Last Updated: 2015-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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This study is a cross-sectional study of 110 Malawian women who present for medical evaluation at the Fistula Care Centre in Lilongwe, Malawi. If a woman enrolls in the study, her demographic, medical history, physical exam, and lab data will be abstracted from her medical records at the Fistula Centre. She will also a pelvic ultrasound on each participant so that the characteristics of her cervix, uterus, and ovaries (such as the cervical length, endometrial thickness and ovarian volume) can be evaluated. If the participant has an obstetric fistula, she will also complete an additional blood draw for lab testing. The laboratory tests will evaluate three hormones that are associated with amenorrhea and infertility: follicle stimulating hormone, estradiol, and antimullerian hormone.

Conditions

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Obstetric Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Malawian women

Malawian women who present for care at the Fistula Care Centre

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. No history of pregnancy
2. History of hysterectomy
3. Current pregnancy or pregnancy within the past six weeks
4. Seriously or terminally ill
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American College of Obstetricians and Gynecologists

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Tang, MD, MSCR

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey Wilkinson, MD

Role: STUDY_DIRECTOR

University of North Carolina

Locations

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Fistula Care Centre

Lilongwe, , Malawi

Site Status

Countries

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Malawi

Other Identifiers

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12-1880

Identifier Type: -

Identifier Source: org_study_id

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