Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
- Registration Number
- NCT01569737
- Lead Sponsor
- HRA Pharma
- Brief Summary
The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ella ella -
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced Assessed Pregnancy Outcomes up to 9 months after pregnancy diagnosis Live birth outcomes:
Healthy baby; Congenital anomaly: a baby born with a congenital anomaly; Neonatal death: a newborn who died during the first 28 days of life; Preterm birth: a baby born at less than 37 weeks of gestational age;
Pregnancy loss outcomes:
Ectopic pregnancy: implantation of the fertilized egg and pregnancy development in a location outside the uterus and attempt to develop in this location; Spontaneous abortion: early fetal death (i.e. less than 20 completed weeks of gestation);
Fetal death:
Intermediate fetal death (between greater than 20 and less than 28 completed weeks of gestation); Late fetal death (greater or equal to 28 completed weeks of gestation);
Induced abortions can be either:
An induced abortion for non-medical reason; An induced abortion for medical reasons (termination of pregnancy for fetal anomaly, or for other pregnancy or maternal health complications)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Planned Parenthood Federation of America, Inc
🇺🇸New York, New York, United States