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ESEP study.


- candidate number1188
- NTR NumberNTR115
- ISRCTNISRCTN37002267
- Date ISRCTN created30-sep-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-aug-2005
- Secondary IDs 
- Public TitleESEP study.
- Scientific TitleRandomised controlled trial of salpingo(s)tomy versus salpingectomy for tubal pregnancy; the impact on future fertility.
- ACRONYMESEP~European Surgery in Ectopic Pregnancy
- hypothesisThe objective is whether the potential advantage of salpingo(s)tomy, i.e. a better fertility prognosis as compared to salpingectomy, outweights the potential disadvantages of this treatment, i.e. persistent trophoblast and an increased risk for ectopic pregnancy.
- Healt Condition(s) or Problem(s) studiedTubal pregnancy, Extra uterine gravidity (EUG)
- Inclusion criteriaWomen with tubal pregnancy and a healthy contra lateral tube.
- Exclusion criteria1. Age < 18 years;
2. Shock;
3. Pregnant after IVF-ET;
4. Known tubal pathology;
5. No fertility wish.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-okt-2004
- planned closingdate1-jan-2010
- Target number of participants450
- InterventionsSalpingotomy versus salpingectomy.
- Primary outcomeSpontaneous vital intra uterine pregnancy.
- Secondary outcomePersistent trophoblast and repeat ectopic pregnancy. A cost-effectiveness analysis will be performed.
- Timepoints
- Trial web sitehttp://www.esepstudy.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. P.J. Hajenius
- CONTACT for SCIENTIFIC QUERIESMD. PhD. P.J. Hajenius
- Sponsor/Initiator European Surgery in Ectopic Pregnancy Study Group
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe ESEP study is an international multi centre randomised controlled trial in a Dutch-Swedish-British collaboration. The objective is whether the potential advantage of salpingo(s)tomy, i.e. a better fertility prognosis as compared to salpingectomy, outweights the potential disadvantages of this treatment, i.e. persistent trophoblast and an increased risk for ectopic pregnancy.
- Main changes (audit trail)
- RECORD10-aug-2005 - 13-apr-2016


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