Condition category
Pregnancy and Childbirth
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
10/10/2014
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 A05217

Study information

Scientific title

Acronym

Study hypothesis

To investigate the feasibility of the misoprostol-only regimen (0.8 mg vaginally or sublingually every 3 hours versus every 12 hours up to three doses).

Ethics approval

Institutional review boards at all participating hospitals and the World Health Organization (WHO) Secretariat Committee on Research on Human Subjects gave ethics approval.

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

Four treatment groups:
A: Sublingual misoprostol every 3 hours
B: Sublingual misoprostol every 12 hours
C: Vaginal misoprostol every 3 hours
D: Vaginal misoprostol every 12 hours

Intervention type

Drug

Phase

Not Applicable

Drug names

Misoprostol

Primary outcome measures

Effectiveness, induction to abortion interval, side effects and acceptability.

Approximate duration of involvement in the study for each subject: first follow-up at 15 days post-treatment, second follow-up (if required) at 42 days, subsequent follow-up as needed.

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, eligible for and requesting medical abortion
2. Agrees to surgical termination should method fail

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2100

Participant exclusion criteria

1. Any indication of serious past or present illness
2. Allergic to misoprostol or with a strong allergic tendency in general
3. Heavy smokers (greater than 20 cigarettes a day)
4. With a scar in the uterus or cervix or any gynaecological anomaly detected with ultrasound
5. A history or evidence of mitral stenosis, glaucoma, or sickle cell anaemia
6. Diastolic blood pressure greater than 90 mmHg
7. Uncontrolled bronchial asthma
8. Systolic blood pressure less than 90 mmHg
9. History or evidence of thromboembolism or liver disease
10. Presence of an intrauterine device in utero
11. Haemolytic disorders

Recruitment start date

01/12/2001

Recruitment end date

01/12/2002

Locations

Countries of recruitment

Armenia, Cuba, Georgia, India, Mongolia, Viet Nam

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

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17560446
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22432980

Publication citations

  1. Results

    von Hertzen H, Piaggio G, Huong NT, Arustamyan K, Cabezas E, Gomez M, Khomassuridze A, Shah R, Mittal S, Nair R, Erdenetungalag R, Huong TM, Vy ND, Phuong NT, Tuyet HT, Peregoudov A, , Efficacy of two intervals and two routes of administration of misoprostol for termination of early pregnancy: a randomised controlled equivalence trial., Lancet, 2007, 369, 9577, 1938-1946, doi: 10.1016/S0140-6736(07)60914-3.

  2. Results

    Rodriguez MI, Seuc A, Kapp N, von Hertzen H, Huong NT, Wojdyla D, Mittal S, Arustamyan K, Shah R, , Acceptability of misoprostol-only medical termination of pregnancy compared with vacuum aspiration: an international, multicentre trial., BJOG, 2012, 119, 7, 817-823, doi: 10.1111/j.1471-0528.2012.03310.x.

Additional files

Editorial Notes