A Phase 4 interventional study of Misoprostol 400mcg Tab and Misoprostol 200mcg Tab in Miscarriage in First Trimester, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 4, Interventional, and Treatment
Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.
Miscarriage is defined by the World Health Organization as the interruption of the pregnancy up to 20-23 weeks, or the products of pregnancy weighing less than 500 grams (1). Nearly 15% of known pregnancies end in miscarriage, especially in the first 12 weeks. Estimates indicate that 68000 women die worldwide each year, as a result of unsafe abortions. Abortions are the major cause of maternal death, particularly in Latin America and the Caribbean. In cases of retained and incomplete abortions, uterine emptying is recommended. In the first trimester of pregnancy, either pharmacological or surgical procedure is accepted according to international guidelines.
Pharmacological treatment for uterine evacuation includes the administration of mifepristone and misoprostol or misoprostol alone. Nevertheless, surgical methods have been shown a greater acceptability and patient satisfaction due to a reduced incidence of adverse effects. Currently, Manual Vacuum Aspiration (MVA) is the technique recommended by the Brazilian Ministry of Health and the Brazilian Federation of Gynecology and Obstetrics.
MVA should be performed after cervical ripening. This pre-surgical procedure makes the procedure safer and more effective. In Brazil, misoprostol is the most suitable drug to be used in these cases because of its efficacy, ease of use, low cost, stability at room temperature, and availability. Misoprostol is a synthetic prostaglandin E1 analog and can be administered by oral, sublingual, buccal, rectal, and vaginal routes.
320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.
This study's enrollment of 211 is above the median of 147 across 174 interventional studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received misoprostol 400 µg: 2 tablets of misoprostol (200µg each) introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration (MVA) procedure.
Drug: Misoprostol 400mcg Tab
Participants received misoprostol 200 µg: 1 tablet of misoprostol introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure.
Drug: Misoprostol 200mcg Tab
400µg of misoprostol (2 tablets)
Also known as: Misoprostol control
200µg of misoprostol (1 tablet)
Also known as: Misoprostol comparator
Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration
this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration
Time frame: baseline at initiation of the Manual Vacuum Aspiration
Number of Participants With a Presence of a Uterine Cervical Canal With ≥8 mm of Dilation
This outcome measures how many mm of dilation the cervical canal has before the procedure. Cervical permeability (≥8 mm of dilation, used as a cut-off) was measured using Karman cannulas, from higher to low diameter.
Time frame: Baseline before Manual Vacuum Aspiration procedure
Pain Score (VAS)
Pain scores were assessed using a verbal analog scale (VAS), ranging from zero (no pain) to 10 (worst possible pain)
Time frame: before Manual Vacuum Aspiration
Participants with diagnosis of miscarriage and scheduled for Manual Vacuum Aspiration at the Gynecologic Emergency Unit of Hospital de Clínicas de Porto Alegre, a tertiary teaching hospital, were recruited. The first participant was enrolled on December 21, 2016.
| Milestone | Misoprostol 400µg | Misoprostol 200µg |
|---|---|---|
| Started | 106 | 105 |
| Completed | 106 | 105 |
| Not completed | 0 | 0 |
this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration
| Participants | Misoprostol 400 µg | Misoprostol 200 µg |
|---|---|---|
| It was necessary (inadequate cervix dilation) | 4 | 16 |
| It was not necessary (adequate cervix dilation) | 102 | 89 |
This outcome measures how many mm of dilation the cervical canal has before the procedure. Cervical permeability (≥8 mm of dilation, used as a cut-off) was measured using Karman cannulas, from higher to low diameter.
| Participants | Misoprostol 400 µg | Misoprostol 200 µg |
|---|---|---|
| Inadequate (<8 mm) | 30 | 50 |
| Adequate (≥8 mm) | 76 | 55 |
Pain scores were assessed using a verbal analog scale (VAS), ranging from zero (no pain) to 10 (worst possible pain)
| units on a scale - Verbal Analog Scale | Misoprostol 400 µg | Misoprostol 200 µg |
|---|---|---|
| Pain Score (VAS) | 0 (0 to 10) | 0 (0 to 10) |
Collected over From the MVA procedure until 6 hours after the procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Misoprostol 400 µg | 0/106 (0%) | 0/106 (0%) | 1/106 (0.9%) |
| Misoprostol 200 µg | 0/105 (0%) | 0/105 (0%) | 3/105 (2.9%) |
| Event | Misoprostol 400 µg | Misoprostol 200 µg |
|---|---|---|
| cervical lacerationReproductive system and breast disorders | 0/106 | 2/105 |
| uterine hemorrhageReproductive system and breast disorders | 1/106 | 1/105 |
| Age, Continuous(years) | Misoprostol 400 µg | Misoprostol 200 | Total |
|---|---|---|---|
| Median | 30 (16 to 46) | 31 (15 to 49) | 30 (15 to 49) |
| Sex: Female, Male(Participants) | Misoprostol 400 µg | Misoprostol 200 | Total |
|---|---|---|---|
| Female | 106 | 105 | 211 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Misoprostol 400 µg | Misoprostol 200 | Total |
|---|---|---|---|
| Black | 29 | 26 | 55 |
| Brazilian indian | 0 | 1 | 1 |
| White | 76 | 77 | 153 |
| Asian | 1 | 1 | 2 |
| Region of Enrollment(participants) | Misoprostol 400 µg | Misoprostol 200 | Total |
|---|---|---|---|
| Brazil | 106 | 105 | 211 |
| Obstetric history(cases) | Misoprostol 400 µg | Misoprostol 200 | Total |
|---|---|---|---|
| Gesta | 2 (1 to 8) | 2 (1 to 8) | 2 (1 to 8) |
| Para | 1 (0 to 7) | 1 (0 to 6) | 1 (0 to 7) |
| Miscarriages | 1 (1 to 7) | 1 (1 to 4) | 1 (1 to 7) |
| Time from misoprostol to procedure(hours) | Misoprostol 400 µg | Misoprostol 200 | Total |
|---|---|---|---|
| Mean | 6.38 ± 1.47 | 6.37 ± 1.28 | 6.37 ± 1.39 |
| Gestational age(weeks) | Misoprostol 400 µg | Misoprostol 200 | Total |
|---|---|---|---|
| Mean | 7 ± 1.4 | 7.1 ± 1.5 | 7.1 ± 1.5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We intend to share raw data with other researchers
Supporting information: Study protocol, Sap, Icf, Csr
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Hospital de Clinicas de Porto Alegre