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Completed

NCT Number: NCT00426491

Misoprostol for Non-Viable Pregnancies

The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

About this study

Patients presenting to the OB/GYN clinic with a nonviable gestation, diagnosis documented by endovaginal ultrasound will be enrolled. Ultrasonic findings will be verified by two of the resident staff from the obstetrics and gynecology department of Madigan Army Medical Center. Patients consenting will be directed to the OB/GYN clinic for evaluation, exam, and counseling and to watch the video giving explanation of purpose of the study and the planned procedure, but also expected side effects and possible complications. Patients will be randomized into two groups: study group receiving Misoprostol per vagina and the control group receiving a placebo per vagina. Subjects will be issued an envelope and go to the pharmacy to pick up their study medication, blinded to them and the provider. They will also be given Motrin and Phenergan to help alleviate undesired side effects. Four 200 ug tablets of Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider. Patients will return in 24 hours for re-examination. If no evidence of an intrauterine pregnancy remains, patients will be informed that their miscarriage was complete, given precautions and asked to make an appointment for follow-up in 4 weeks in addition to weekly visits to the lab for quantitative BHCG. All patients will be followed until the quantitative BHCG has fallen zero to ensure resolution of the pregnancy event.

Patients with evidence of a gestational sac will be given a second dose of Misoprostol or a D&C if they choose to withdraw from the study or a surgical intervention if it is deemed clinically indicated by the attending staff. Again, subjects will be given appropriate counseling and precautions and asked to follow up in an additional 24 hours for re-evaluation. Surveys will be given at each visit and follow up to evaluate patient satisfaction and also to query for unintended side effects and complications.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant patients with nonviable pregnancy document by ultrasound
  • Gestation at or less than 13 weeks by ultrasound measurements
  • Clinically stable as determined by provider
  • Afebrile
  • Hematocrit > 30
  • Over 18 years of age

Exclusion criteria

  • History of allergy to, or intolerance of, misoprostol
  • Refusal to abstain from intercourse for 72 hours
  • Significant vaginal bleeding (> 2 pad/hr)
  • History of inflammatory bowel disease

Treatment and study plan

Misoprostol

Drug

400 ug Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider.

Other names: Cytotec

Primary outcomes

  1. time to resolution

    Time frame: 24hrs, and then weekly, after insertion

  2. percentage requiring dilation and curettage

    Time frame: 24hrs, and then weekly, after insertion

  3. failure to expel products of conception

    Time frame: 24hrs, and then weekly, after insertion

  4. change in hematocrit

    Time frame: 24hrs, and then weekly, after insertion

  5. side effects

    Time frame: 24hrs, and then weekly, after insertion

  6. BHCG level

    Time frame: 24hrs, and then weekly, after insertion

Sponsors and collaborators

Lead sponsor

Madigan Army Medical Center

Fed

Registry information

Official study title

Misoprostol for the Medical Management of Non-Viable First Trimester Pregnancies

Important dates

Study start
1999
Primary completion
2006
Study completion
2006
First posted
Jan 24, 2007
Registry last updated
Feb 8, 2008

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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