Skip to main content
OpenTrials
Completed

NCT Number: NCT01569737

Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Emergency Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood Federation of America, Inc

New York, 10001, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

ella

Drug

ella, single intake, tablet 30mg

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

HRA Pharma

Industry

Registry information

Official study title

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

Acronym: ellipseII

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2012
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.