Randomised controlled trial of salpingostomy versus salpingectomy for tubal pregnancy, the impact of future fertility
| ISRCTN | ISRCTN37002267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37002267 |
| Protocol serial number | N0116151801 |
| Sponsor | European Surgery in Ectopic Pregnancy Study Group |
| Funders | King's College Hospital NHS Trust R&D Consortium (UK), NHS R&D support funding (UK), Netherlands Organisation for Health Research and Development |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 17/07/2015
- 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 of protocol
Not provided at time of registration
Contact information
Mrs P J Hajenius
Scientific
Scientific
Department of Obstetrics and Gynaecology
Academic Medical Center
University of Amsterdam
P.O. Box 22700
Amsterdam
1100 DE
Netherlands
| Phone | +31 (0)20 5663654 |
|---|---|
| esep@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial of salpingostomy versus salpingectomy for tubal pregnancy, the impact of future fertility |
| Study acronym | ESEP study - European Surgery in Ectopic Pregnancy |
| Study objectives | Whether the potential advantage of salpingostomy (opening the fallopian tube to remove pregnancy) i.e. better fertility prognosis as compared to salpingectomy (removing the fallopian tube with the pregnancy), outweighs the potential disadvantages of this treatment i.e. persistent trophoblast and an increased risk for ectopic pregnancy. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Tubal pregnancy |
| Intervention | Salpingostomy versus salpingectomy. |
| Intervention type | Other |
| Primary outcome measure(s) |
Time to occurrence of a spontaneous intra uterine pregnancy. |
| Key secondary outcome measure(s) |
Persistent trophoblast and repeat ectopic pregnancy. A cost-effectiveness analysis will be performed. |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 450 |
| Key inclusion criteria | Women with tubal pregnancy and a healthy contra-lateral tube. |
| Key exclusion criteria | 1. Aged less than 18 years 2. Shock 3. Pregnant after In Vitro Fertilisation and Embryo Transfer (IVF-ET) 4. Known tubal pathology 5. No fertility wish |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- United Kingdom
- Netherlands
- Sweden
Study participating centre
Academic Medical Center
Amsterdam
1100 DE
Netherlands
1100 DE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 26/04/2014 | Yes | No | |
| Results article | results | 01/09/2015 | Yes | No | |
| Protocol article | protocol | 26/06/2008 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
