Blood Loss Clinical Trial
— Preop MisoOfficial title:
Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester
Verified date | March 2014 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to aid in softening the cervix as well as decreasing blood loss after abortion or vaginal delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester surgical abortion decreases blood loss from the procedure. The investigators will also assess whether misoprostol improves cervical dilation, changes the length of the procedure, changes the need for additional mechanical dilation, changes the subjective ease of the procedure, and changes a woman's pain.
Status | Terminated |
Enrollment | 2 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - English or Spanish speaking - Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound dating on the day of enrollment - Ultrasound used for dating purposes must be within the last two weeks. - Women 18-50 years of age undergoing surgical termination of pregnancy Exclusion Criteria: - Spontaneous fetal demise - Ruptured membranes or intrauterine infection - Fibroids that significantly distort the uterine shape - Uterine abnormality such as unicornuate uterus - Prior transmural myomectomy - Severe oligohydramnios - Morbid obesity with BMI>45 - Inability to place osmotic dilators |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Boston University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood loss | Measured blood loss | Subjects will be followed for the duration of their procedure visit, lasting one day. | Yes |
Secondary | Cervical dilation | Subjects will be followed for the duration of their procedure visit, lasting one day. | Yes | |
Secondary | Length of the procedure | Subjects will be followed for the duration of their procedure visit, lasting one day. | No | |
Secondary | Need for additional mechanical dilation | Subjects will be followed for the duration of their procedure visit, lasting one day. | Yes | |
Secondary | Subjective provider ease of procedure | Subjects will be followed for the duration of their procedure visit, lasting one day. | No | |
Secondary | Subject pain before the procedure | Subjects will be followed for the duration of their procedure visit, lasting one day. | No | |
Secondary | Subject pain during the procedure | Subjects will be followed for the duration of their procedure visit, lasting one day. | No |
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