Condition category
Pregnancy and Childbirth
Date applied
18/02/2009
Date assigned
06/03/2009
Last edited
29/07/2014
Prospective/Retrospective
Prospectively 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

Prof Janesh Kumar Gupta

ORCID ID

Contact details

Birmingham Women's Hospital
Second Floor
Academic Department
Metchely Park Road
Edgbaston
Birmingham
B15 2TG
United Kingdom
+44 (0)121 607 4751
j.k.gupta@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TIMES/09-012/11

Study information

Scientific title

A randomised controlled trial on Efficacy of mifepristone followed by 6-8 hours versus 24 hours vaginal misoprostol in Early Medical Abortions (< 63 days gestation)

Acronym

TIMES Study (Time Interval for Medical Early abortionS)

Study hypothesis

The hypothesis for this study is to determine the efficacy of shorter time intervals of administration of misoprostol and also to assess the reliability of follow-up methods to confirm completeness of medical abortion. To explore women’s beliefs and preferences to different medical methods within the framework of the randomised controlled trial.

Ethics approval

Pending, to be submitted by March 2009 (as of 18/02/2009)

Study design

Non-inferiority randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Early medical abortion

Intervention

800 ug of misoprostol given vaginally after 200 mg of mifepristone at 6-8 hours interval or 24 hours interval

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To determine the proportion of complete abortions where no further medical or surgical intervention beyond the initial dose of vaginal misoprostol required.

Secondary outcome measures

1. Induction to abortion interval
2. Adverse effects
3. Pain
4. Bleeding
5. Acceptability of women towards the new regimen
6. Assess reliability of follow-up methods following medical abortion

The end point for all secondary outcomes will be at the end of 2 weeks.

Overall trial start date

01/06/2009

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ability to give informed written consent
2. Women who are 18 years and older
3. Requesting abortion and eligible for legal termination of pregnancy
4. Duration of pregnancy not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle or verified by ultrasound
5. The pregnancy is single and intrauterine (single sac)
6. Agree to be able to be contacted by telephone (i.e. mobile telephone)
7. Women with limited understanding of English will be included only in the quantitative study where interpreters are available

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1,200

Participant exclusion criteria

1. Any indication of serious past or present ill health will be considered a contraindication for recruitment to the study
2. Suspicion of any pathology of pregnancy (e.g. molar, non-viable pregnancy, threatened abortion)
3. Current participation in a drug-related trial
4. Non-English-speaking women for the qualitative study
5. Women under the age of 18 years

Recruitment start date

01/06/2009

Recruitment end date

01/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom

Sponsor information

Organisation

Calthorpe Clinic (UK)

Sponsor details

c/o Carolyn Philips
4 Arthur Road
Edgbaston
Birmingham
B15 2UL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.calthorpe-clinic.co.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Calthorpe Clinic (UK)

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

Publication citations

Additional files

Editorial Notes