Does patient ambulation affect the induction to abortion internal in early medical termination of pregnancy up to 63 days gestation?
| ISRCTN | ISRCTN62622140 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62622140 |
| Secondary identifying numbers | N0236173578 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 30/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mrs Patricia Wood
Scientific
Scientific
Pregnancy Advisory Service
Lanesborough Wing
Colposcopy Office
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
| Phone | +44 (0)20 8725 0155 |
|---|---|
| Patricia.Wood@stgeorges.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 01/11/2005 |
| Overall study end date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| 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 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
- England
- United Kingdom
Study participating centre
Pregnancy Advisory Service
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
St George's Healthcare NHS Trust (UK) NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2012 | Yes | No |
