Trial Outcomes & Findings for Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage (NCT NCT02957305)

Last Updated: 2021-04-30

Results Overview

this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

211 participants

Primary outcome timeframe

baseline at initiation of the Manual Vacuum Aspiration

Results posted on

2021-04-30

Participant Flow

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.

A total of 269 were screened. From these, 211 were enrolled and randomized to treatment. After randomization, 2 cases, one case of infected abortion and one case with previous cervical conization were identified and they were treated as for intention to treat.

Participant milestones

Participant milestones
Measure	Misoprostol 400µg Participants received misoprostol 400 µg: 2 tablets of misoprostol (200µg each) were introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure. Misoprostol: 400µg	Misoprostol 200µg Participants received misoprostol 200 µg: 1 tablet was introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure. Misoprostol: 200µg
Overall Study STARTED	106	105
Overall Study COMPLETED	106	105
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Misoprostol 400 µg n=106 Participants Misoprostol 400 µg 6 hours before Manual Vacuum Aspiration	Misoprostol 200 n=105 Participants Misoprostol 200 µg 6 hours before Manual Vacuum Aspiration	Total n=211 Participants Total of all reporting groups
Age, Continuous	30 years n=5 Participants	31 years n=7 Participants	30 years n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	105 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	29 participants n=5 Participants	26 participants n=7 Participants	55 participants n=5 Participants
Race/Ethnicity, Customized Brazilian indian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	76 participants n=5 Participants	77 participants n=7 Participants	153 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Brazil	106 participants n=5 Participants	105 participants n=7 Participants	211 participants n=5 Participants
Obstetric history Gesta	2 cases n=5 Participants	2 cases n=7 Participants	2 cases n=5 Participants
Obstetric history Para	1 cases n=5 Participants	1 cases n=7 Participants	1 cases n=5 Participants
Obstetric history Miscarriages	1 cases n=5 Participants	1 cases n=7 Participants	1 cases n=5 Participants
Time from misoprostol to procedure	6.38 hours STANDARD_DEVIATION 1.47 • n=5 Participants	6.37 hours STANDARD_DEVIATION 1.28 • n=7 Participants	6.37 hours STANDARD_DEVIATION 1.39 • n=5 Participants
Gestational age	7 weeks STANDARD_DEVIATION 1.4 • n=5 Participants	7.1 weeks STANDARD_DEVIATION 1.5 • n=7 Participants	7.1 weeks STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: baseline at initiation of the Manual Vacuum Aspiration

Population: Intention to Treat Population (all participants assigned to misoprostol 400µg or 200µg)

this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration

Outcome measures

Outcome measures
Measure	Misoprostol 400 µg n=106 Participants Misoprostol 400 µg 6 hours before intrauterine suction Misoprostol 400 µg: evaluate the required cervix dilation in the moment of the intrauterine suction	Misoprostol 200 µg n=105 Participants Misoprostol 200 µg 6 hours before intrauterine suction Misoprostol 200 µg: evaluate the required cervix dilation in the moment of the intrauterine suction
Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration It was necessary (inadequate cervix dilation)	4 Participants	16 Participants
Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration It was not necessary (adequate cervix dilation)	102 Participants	89 Participants

SECONDARY outcome

Timeframe: Baseline before Manual Vacuum Aspiration procedure

Population: Intention to Treat (all patients assigned to 400mg or 200µg of misoprostol)

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.

Outcome measures

Outcome measures
Measure	Misoprostol 400 µg n=106 Participants Misoprostol 400 µg 6 hours before intrauterine suction Misoprostol 400 µg: evaluate the required cervix dilation in the moment of the intrauterine suction	Misoprostol 200 µg n=105 Participants Misoprostol 200 µg 6 hours before intrauterine suction Misoprostol 200 µg: evaluate the required cervix dilation in the moment of the intrauterine suction
Number of Participants With a Presence of a Uterine Cervical Canal With ≥8 mm of Dilation Inadequate (<8 mm)	30 Participants	50 Participants
Number of Participants With a Presence of a Uterine Cervical Canal With ≥8 mm of Dilation Adequate (≥8 mm)	76 Participants	55 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: before Manual Vacuum Aspiration

Pain scores were assessed using a verbal analog scale (VAS), ranging from zero (no pain) to 10 (worst possible pain)

Outcome measures

Outcome measures
Measure	Misoprostol 400 µg n=106 Participants Misoprostol 400 µg 6 hours before intrauterine suction Misoprostol 400 µg: evaluate the required cervix dilation in the moment of the intrauterine suction	Misoprostol 200 µg n=105 Participants Misoprostol 200 µg 6 hours before intrauterine suction Misoprostol 200 µg: evaluate the required cervix dilation in the moment of the intrauterine suction
Pain Score (VAS)	0 units on a scale - Verbal Analog Scale Interval 0.0 to 10.0	0 units on a scale - Verbal Analog Scale Interval 0.0 to 10.0

Adverse Events

Misoprostol 400 µg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Misoprostol 200 µg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Misoprostol 400 µg n=106 participants at risk Misoprostol 400 µg 6 hours before MVA	Misoprostol 200 µg n=105 participants at risk Misoprostol 200 µg 6 hours before MVA
Reproductive system and breast disorders uterine hemorrhage	0.94% 1/106 • Number of events 1 • From the MVA procedure until 6 hours after the procedure	0.95% 1/105 • Number of events 1 • From the MVA procedure until 6 hours after the procedure
Reproductive system and breast disorders cervical laceration	0.00% 0/106 • From the MVA procedure until 6 hours after the procedure	1.9% 2/105 • Number of events 2 • From the MVA procedure until 6 hours after the procedure

Additional Information

Ricardo Francalacci Savaris

Dep. of Obstetrics and Gynecology, Universidade Federal do Rio Grande do Sul, Porto Alegre - RS - Brazil

Phone: +5551997781966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place