Misoprostol Versus Dilapan-S for Cervical Preparation

Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00835731

Enrollment

125

Registered

2009-02-04

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ripening

Keywords

induced abortion, misoprostol, cervical ripening, second trimester abortion, Dilapan-S

Brief summary

The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.

Interventions

DRUGmisoprostol

400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E

DEVICEDilapan-S, vitamin B-12

One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts * gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound * proficient in English or Spanish * agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction

Exclusion criteria

* less than 18 years old * cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure * inflammatory bowel disease * contraindication to misoprostol use * known intolerance or allergy to misoprostol or Dilapan-S * inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Cervical Dilation in Women Following Exposure to Either Ripening Agent	3-4 hours after placement of ripening agent

Secondary

Measure	Time frame	Description
Procedure Time for Dilation and Evacuation	3-4 hours after placement of ripening agent	—
Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt	3-4 hours after placement of ripening agent	—
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report	3-4 hours after placement of ripening agent	Scale: None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5)
Subject Pain During Dilation and Evacuation	3-4 hours after placement of ripening agent	Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale: 0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain Higher values represent a worse outcome.
Women's Satisfaction With Cervical Ripening Method	5 hours after placement of ripening agent	Scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied
Subject Pain During Ripening	3-4 hours after placement of ripening agent	Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale: 0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain Higher values represent a worse outcome.

Countries

United States

Participant flow

Recruitment details

Dates of recruitment period: January 2009 - December 2011 We recruited English- or Spanish-speaking women who were in good health, at least 18 years old, and between 12 weeks 0 days and 15 weeks 0 days gestation by ultrasound examination, seeking outpatient pregnancy termination at Planned Parenthood League of MA.

Pre-assignment details

Patients were recruited for study participation on the day of their pregnancy termination procedure. All study procedures occurred on the day that the patient was enrolled.

Participants by arm

Arm	Count
Misoprostol 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E	64
Synthetic Osmotic Dilator Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E	61
Total	125

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Physician Decision	1	1
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Misoprostol	Synthetic Osmotic Dilator	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	64 Participants	61 Participants	125 Participants
Age, Continuous	24.1 years STANDARD_DEVIATION 5.5	24.0 years STANDARD_DEVIATION 5	24.0 years STANDARD_DEVIATION 5.2
Sex: Female, Male Female	64 Participants	61 Participants	125 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	3 / 62	3 / 60
serious Total, serious adverse events	0 / 62	0 / 60