Condition category
Pregnancy and Childbirth
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
11/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helena von Hertzen

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
vonhertzenh@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID A15065

Study information

Scientific title

Acronym

Study hypothesis

To compare two treatment regimens (0.4 mg misoprostol administered sublingually versus vaginally every three hours up to five doses) for the termination of pregnancy in women with a length of amenorrhoea between 14 to 20 weeks.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Induced abortion

Intervention

Misoprostol (0.4 mg) either vaginally or sublingually every three hours up to five doses.

Approximate duration of involvement in the study for each subject: first follow up at 15 days post-treatment, another follow-up visit will be carried out according to the practice of the hospital.

Intervention type

Drug

Phase

Not Specified

Drug names

Misoprostol

Primary outcome measures

1. The effectiveness to induce complete or partial abortion/induction-to-abortion interval
2. The frequency of side effects
3. Acceptability of treatment to women

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/12/2001

Overall trial end date

01/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy women
2. Eligible for and requesting legal termination of second trimester pregnancy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

680

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/12/2001

Recruitment end date

01/12/2002

Locations

Countries of recruitment

Armenia, Georgia, Hungary, India, Slovenia, South Africa, Viet Nam, Zambia

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction

Sponsor details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int/reproductive-health/hrp/

Funders

Funder type

Research organisation

Funder name

United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15327617
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18794161

Publication citations

  1. Results

    Tang OS, Lau WN, Chan CC, Ho PC, A prospective randomised comparison of sublingual and vaginal misoprostol in second trimester termination of pregnancy., BJOG, 2004, 111, 9, 1001-1005, doi: 10.1111/j.1471-0528.2004.00222.x.

  2. Results

    von Hertzen H, Piaggio G, Wojdyla D, Nguyen TM, Marions L, Okoev G, Khomassuridze A, Kereszturi A, Mittal S, Nair R, Daver R, Pretnar-Darovec A, Dickson K, Nguyen DH, Nguyen HB, Hoang TD, Peregoudov A, , Comparison of vaginal and sublingual misoprostol for second trimester abortion: randomized controlled equivalence trial., Hum. Reprod., 2009, 24, 1, 106-112, doi: 10.1093/humrep/den328.

Additional files

Editorial Notes