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Completed

NCT Number: NCT01891149

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

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.

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Key information

Conditions

Obstetric Fistula

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fistula Care Centre

Lilongwe, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Cervical length

    Time frame: baseline

Secondary outcomes

  1. Hormonal levels

    Time frame: baseline

    FSH, Estradiol, AMH

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American College of Obstetricians and Gynecologists

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2013
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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