Prospective Multicenter Observational Study to Assess Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
Overview
- Phase
- N/A
- Intervention
- ella
- Conditions
- Emergency Contraception
- Sponsor
- HRA Pharma
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Experienced Assessed Pregnancy Outcomes
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ella
Intervention: ella
Outcomes
Primary Outcomes
Number of Participants Who Experienced Assessed Pregnancy Outcomes
Time Frame: 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)