A Prospective Randomized Comparison Trial on the Use of Mifepristone With Sublingual or Buccal Misoprostol for Medical Abortions of Less Than 9 Weeks Gestation

NCT01156688 | Completed Phase 4 DMC

• 1 other identifier: HKCTR-1069
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the incidence of side effects of buccal and sublingual misoprostol when combined with mifepristone for medical abortions of less than 9 weeks gestation. The secondary outcome is to compare the complete abortion rate and induction-abortion interval between the two methods of administration of misoprostol.

Conditions

Abortion, Legal

Keywords

medical abortion for pregnancy of less than 9 weeks gestation

Outcome Measures

Primary Outcomes (1)

• to compare the incidence of side effects of buccal and sublingual misoprostol when combined with mifepristone for medical abortions of less than 9 weeks gestation.

  within 43 days after mifepristone

Secondary Outcomes (2)

• to compare the complete abortion rate

  up to the time when patient's return of next mense, on average within 60 days after mifepristone

• to compare the induction-abortion interval

  from insertion of misoprostol to day of abortion process, within 15 days after mifepristone

Study Arms (2)

Sublingual Misoprostol

ACTIVE COMPARATOR

Drug: Misoprostol

Buccal misoprostol

ACTIVE COMPARATOR

Drug: Misoprostol

Interventions

Misoprostol DRUG

sublingual 800mcg misoprostol 48 hours after oral 200mg mifepristone

Sublingual Misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• good general health
• older than the age of legal consent (i.e. \>18 years old)
• requesting medical abortion and eligible for abortion
• on Day 1 of the study (day of mifepristone administration) the duration of pregnancy not more than 63 days as confirmed by pelvic ultrasound examination
• intrauterine pregnancy (intrauterine amniotic sac seen in US)
• willing to use other than hormonal or intra-uterine contraception until the first menses after termination of pregnancy
• if treatment fails she agrees to termination of pregnancy with the surgical method
• willing and able to participate after the study has been explained
• haemoglobin higher than 10g/L

You may not qualify if:

• a history or evidence of adrenal pathology, steroid-dependent cancer, porphyria, diastolic pressure over 95mm Hg, bronchial asthma, arterial hypotension.
• a history or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy
• the regular use of prescription drugs before admission to the study
• the presence of an IUCD in utero
• breast-feeding
• multiple pregnancies
• heavy smokers

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Family Planning Association

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Joyce Chai, MBChB

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 5, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 5, 2011

Record last verified: 2011-08

Locations

HK (1)