Follow-up and Outcomes of Pregnancies Exposed to ellaOne
Research type
Research Study
Full title
Prospective Observational Study to Assess Clinical Follow-up and Outcomes of Pregnancies Exposed to ellaOne
IRAS ID
163907
Contact name
Patricia Lohr
Contact email
Sponsor organisation
HRA Pharma
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
ellaOne (ulipristal acetate 30 mg tablet) is licensed for use as an oral emergency contraceptive pill that can be taken up to 120 hours after unprotected sexual intercourse. During the clinical development phase, only a small number of pregnancies occurred following administration of ellaOne leading the European Medicines Agency and US Food and Drug Administration to request additional information on the potential effects of ellaOne exposure on pregnancy course and outcome. Initial attempts at collecting this information through a voluntary registry were unsuccessful. The manufacturers of ellaOne, HRA Pharma, have therefore implemented a prospective multisite observational study to collate data on pregnancies that are carried to term and delivered, those that miscarry or are ectopic, and those that are terminated. BPAS’ participation will be limited to providing data on women in the latter three groups.
BPAS clients who used ellaOne to avert their current pregnancy or who inadvertently used it during the pregnancy will be identified at the time of consultation and invited to take part. Following consent, an anonymous data collection form will be completed by the clinician. The form collates data on pregnancy diagnosis and exposure to ellaOne, medical and obstetric history, the status of the pregnancy (including as assessment of gestational age and viability by ultrasound), outcome (termination, miscarriage, ectopic), and any complications within 2 weeks of treatment. The data collected will be pooled with all reports of pregnancies collected by the HRA Pharma. Pregnancy outcomes will be analysed on the pooled dataset.
Descriptive statistics will be generated with 95% confidence intervals. Specific data to be reported on women terminating include the proportion of normal-appearing pregnancies by ultrasound and rate of adverse events with treatment, particularly related to excessive or prolonged vaginal bleeding.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
14/SW/1155
Date of REC Opinion
24 Nov 2014
REC opinion
Favourable Opinion