Condition category
Pregnancy and Childbirth
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
30/08/2013
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

Mrs Patricia Wood

ORCID ID

Contact details

Pregnancy Advisory Service
Lanesborough Wing
Colposcopy Office
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
+44 (0)20 8725 0155
Patricia.Wood@stgeorges.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236173578

Study information

Scientific title

Acronym

Study hypothesis

To investigate if encouraging ambulation following administration of misoprostol reduces the induction-to-abortion interval in termination of first trimester pregnancy up to 9 weeks.

Women requesting early medical termination of pregnancy often cite a desire for a more natural experience as a reason for choosing the method. A reluctance for the abortion to be medicalised often figures largely in their decision making process. An opportunity to accommodate this less intrusive approach is lost when the protocol stipulates that the patient must remain on the hospital ward for the duration of the abortion. Ambulation following misoprostol administration is common but the benefits/disadvantages of this approach have not been investigated.

A prospective randomised trial comparing the progress of ambulatory patients with that of non-ambulatory patients is proposed.

Patients will be recruited from the termination of pregnancy clinic.

Patients requesting early medical termination of first trimester pregnancy up to 9 weeks gestation will be offered the opportunity to participate in the study.

The participants will be randomly assigned to one of two groups. Group one will be required to remain on the ward and for the first hour following misoprostol administration will be confined to the recliner chair in a semi-recumbent position. After misoprostol administration, Group two will be encouraged to mobilise immediately and following a fifteen minute observation period will be encouraged to leave the ward and walk around the hospital. Both patient groups will be encouraged to report first symptoms of cramping and first evidence of bleeding to the supervising nurse on the ward. All patients will be obliged to return to the ward when bleeding commences or after four hours, whichever is sooner. The time that products of conception are passed will be recorded. Data will be collated with respect to gestation and gravida to ensure a like with like comparison. Those patients who do not wish to participate will follow the current protocol which requires them to remain on the ward until the products of conception are passed.

The anxiety level and the anxiety state of patients in both the groups will be assessed by the Spielberger Self-Evaluation questionnaire. The questionnaire will be given to the patients after the administration of misoprostol and will be asked to be filled in by the patient herself. The scores from the individual questions will be totalled and a final score for each patient will be obtained which will be used for statistical analysis to detect any significant difference between both the groups.

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

Pregnancy and Childbirth: Abortion

Intervention

The participants will be randomly assigned to one of two groups. Group one will be required to remain on the ward and for the first hour following misoprostol administration will be confined to the recliner chair in a semi-recumbent position. After misoprostol administration, Group two will be encouraged to mobilise immediately and following a fifteen minute observation period will be encouraged to leave the ward and walk around the hospital. Both patient groups will be encouraged to report first symptoms of cramping and first evidence of bleeding to the supervising nurse on the ward. All patients will be obliged to return to the ward when bleeding commences or after four hours, whichever is sooner. The time that products of conception are passed will be recorded. Data will be collated with respect to gestation and gravida to ensure a like with like comparison. Those patients who do not wish to participate will follow the current protocol which requires them to remain on the ward until the products of conception are passed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The induction to abortion interval
2. Hospital in-patient time ie admission to discharge interval

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2005

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women attending for medical termination of pregnancy of gestation below 63 days. Medical termination of pregnancy at this gestation is known to be a safe and predictable procedure. Patients will be approached at clinic and the study explained verbally and written information outlining the study will be given. Patient involvement will be discussed after mifepristone administration and consent for inclusion in the study obtained. Patients will be able to withdraw from the study at any time.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Patients under the age of 16 years
2. Adults with a learning disability
3. Patients whose pregnancy exceeds 63 days gestation

Recruitment start date

01/11/2005

Recruitment end date

31/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pregnancy Advisory Service
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

St George's Healthcare NHS Trust (UK) NHS R&D Support Funding

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22036045

Publication citations

  1. Results

    Ojha K, Gillott DJ, Wood P, Valcarcel E, Matah A, Talaulikar VS, Clinical outcomes from a prospective study evaluating the role of ambulation during medical termination of pregnancy., Contraception, 2012, 85, 4, 398-401, doi: 10.1016/j.contraception.2011.08.008.

Additional files

Editorial Notes