Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

Emergency Contraception Clinical Trial

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Official title:

Prospective Multicenter Observational Study to Assess Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569737
• Other study ID #: 2914-012
• Status: Completed
• Start date: November 18, 2014
• Est. completion date: June 29, 2018

Study information

• Verified date: September 2019
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

• Pregnant women, exposed to ella during the menstrual cycle in which the pregnancy started (treatment failure) or at any time during pregnancy (inadvertent exposure during pregnancy)

• Adolescents and/or adults in the USA, depending on the respective State law

Related Conditions & MeSH terms

• Emergencies
• Emergency Contraception

Intervention

Drug:
• ella
ella, single intake, tablet 30mg

Locations

Country	Name	City	State
United States	Planned Parenthood Federation of America, Inc	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Assessed Pregnancy Outcomes	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)	up to 9 months after pregnancy diagnosis