Phase 4
Completed N=211
Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage
Miscarriage in First Trimester
Source: ClinicalTrials.gov NCT02957305 ↗
Enrolled (actual)
211
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration — 4; 16; 102; 89 Participants — p=0.025
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration |
4; 16; 102; 89 | 0.025 sig |
| SECONDARY Number of Participants With a Presence of a Uterine Cervical Canal With ≥8 mm of Dilation |
30; 50; 76; 55 | — |
Eligibility Criteria
Inclusion Criteria
- All patients admitted at the Gynecological emergency Unit at Hospital de Clínicas de Porto Alegre scheduled for uterine evacuation with 14000]);
- patients with twin pregnancy;
- patients with Marfan syndrome;
- patients allergic to misoprostol;
- patients with coagulopathy;
- patients with opening of cervical internal os (4 mm of dilatation at the time of consultation);
- patients with previous surgery of the cervix (conization);
- patients with concomitant use of IUDs.
Data sourced from ClinicalTrials.gov (NCT02957305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.