Federal Government. Read our disclaimer for details. Last Update Posted : December 6, Study Description. Detailed Description:. Drug Information available for: Misoprostol. FDA Resources. Arms and Interventions. For patient with miscarriage complications or not, or threatened miscarriage there will be a urine collection the day of the inclusion.
Outcome Measures. Primary Outcome Measures : Detection of misoprostol in urine sample [ Time Frame: Enrollment visit ] A descriptive analysis of variable is planned. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Accepts Healthy Volunteers: No Criteria. Inclusion Criteria: inclusion criteria: All patients who come at the maternity emergency unit for miscarriage or threatened miscarriage by 24 weeks of amenorrhea or patient receiving misoprostol for voluntary abortion. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Non-medical abortion Misoprostol miscarriage complications Guadeloupe. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. Used 2 days after mifepristone, it increases the success rate of a medical abortion.
Conventional timing mandates misoprostol administration 48 hours after mifepristone, but no studies have investigated alternative schedules. The US Food and Drug Administration's labeling of mifepristone may require misoprostol to be used in a clinical setting 2 days after mifepristone, with clinical monitoring for up to 4 hours, as occurs in France.
In the United States, many clinicians likely would not want to administer mifepristone on a Thursday or Friday because they generally do not have office hours 2 days later during the weekend, when misoprostol would be taken. It is evident from US trials of methotrexate and misoprostol 7 , 8 and mifepristone and misoprostol 4 , 9 that women can safely self-administer misoprostol outside the clinic.
We hypothesized that the 2-day protocol was unnecessarily restrictive and that misoprostol could be administered at home from 1 to 3 days after mifepristone administration, without compromising effectiveness.
This study was a prospective, open-label, randomized multicenter trial. Randomization was stratified by site. Sixteen sites participated, including hospital abortion services, abortion clinics, private family practice offices, and gynecology offices.
All sites had institutional review board approval and all participants provided written informed consent. Study drug was supplied by the Abortion Rights Mobilization. Participants were at least 18 years old, no more than 56 days pregnant, healthy, and desired an abortion of a confirmed intrauterine pregnancy.
The inclusion and exclusion criteria and method of routine gestational dating by ultrasonography followed previously reported protocols. On study day 1, women drew their concealed, computer-generated randomized assignments of misoprostol 1, 2, or 3 days after mifepristone.
Women then received mifepristone, mg, in the office and were instructed to use the vaginal misoprostol between 7 AM and midnight on their assigned day. Women in the group assigned to use misoprostol 1 day after mifepristone were instructed to wait at least 24 hours before using misoprostol but could administer it until midnight of the assigned day.
Women had the option of inserting the misoprostol at home or returning to the office for administration by clinic staff. Women were provided with acetaminophen with codeine as analgesia. All women using misoprostol at home were required to have an emergency plan to seek medical care in case bleeding became excessive. Women returned for their follow-up visit at their discretion anytime between 1 day after misoprostol use to 7 days after mifepristone administration ie, study day 8.
At the first follow-up visit, if ultrasonography demonstrated that the gestational sac was no longer present, the abortion was considered complete. At the second follow-up visit, if the gestational sac was still present but there had been no interval growth, patients were permitted to keep waiting for a successful medical abortion and to return on or before study day If there had been interval growth, indicating an ongoing pregnancy, an aspiration curettage was performed.
An aspiration curettage was also performed if a gestational sac was still present at study day 36 or if excessive bleeding or other severe symptoms occurred at any time. At each visit, we interviewed patients about symptoms and use of medications. Patients who requested oral contraceptive pills started taking them on the first Sunday after vaginal bleeding started after a documented complete abortion.
Women reported by telephone or postcard the date when vaginal bleeding stopped. After the abortion was confirmed by ultrasonography, regardless of whether it was a successful medical abortion or an aspiration curettage following a failed medical abortion, participants completed an acceptability questionnaire.
Patients used Likert scales strongly disagree, disagree, neutral, agree, or strongly agree to rate the acceptability of the overall procedure, cramping pain, bleeding, adverse effects from the medications, waiting time to complete abortion, willingness to recommend using misoprostol at home, willingness to recommend the procedure to another woman, and willingness to choose medical abortion again if they ever wanted another abortion.
We combined the ratings of "agree" and "strongly agree" for our analysis. Women were considered lost to follow-up if there was no documentation of their outcomes after multiple attempts by study personnel to contact them by telephone and certified letter. We accepted documentation of a negative home pregnancy test result as evidence of a complete medical abortion for women who did not return for follow-up.
Data were analyzed using SAS Version 6. Sixteen sites enrolled patients between March and June Table 1 shows that the initial demographic and clinical characteristics of the 3 misoprostol groups were similar. About three quarters of the patients were white, with approximately half reporting at least 1 prior live birth and half reporting at least 1 prior abortion. The mean age was 28 years and the mean length of current pregnancy was 46 days. Table 2 shows the number of patients who completed their correct random assignment.
Only 12 patients chose to use misoprostol in the office setting rather than at home. Forty patients 1. Another 56 2. The remaining patients were the focus of subsequent analyses. Effectiveness rates appear in Table 3. A complete medical abortion was evidenced by a negative home pregnancy test result among 60 women 2. The results were also similar for the patients who used misoprostol on the wrong day.
Among the 51 patients from the compliant group who had aspiration curettage, 27 patients had delayed excessive bleeding occurring at a mean SD of 28 18 days in the 3 groups and requiring surgical intervention; 1 patient had excessive bleeding at 9 hours after misoprostol; 16 patients had a continuing pregnancy; 4 patients had persistent nonviable pregnancies with the longest followed up to day 29; 2 patients elected to have surgical curettage for nonmedical reasons; and 1 patient received surgical curettage because of excessive pain.
At their next follow-up, only 16 women had a gestational sac present. No women required follow-up through study day There were no differences among groups. Table 5 shows adverse effects that were reportedly made worse from either mifepristone or misoprostol compared with the baseline of symptoms from early pregnancy. The most intense cramping and bleeding generally lasts for hours, but these times may vary. Some women bleed heavily for up to 48 hours and may pass clots days or even weeks after taking Misoprostol.
This is common and not dangerous, unless you soak through more than two maxi pads per hour for 2 hours or more, or when you pass clots bigger than an orange. It is normal for your body to take time to empty the uterus completely. Every individual body is different. Share this page.
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