Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella (ellipseII)

September 26, 2019 updated by: HRA Pharma

Prospective Multicenter Observational Study to Assess 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Planned Parenthood Federation of America, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women who have been exposed to ella during the menstrual cycle in which the pregnancy started or at any time during pregnancy will be enrolled in the study.

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ella
Drug: ella
ella, single intake, tablet 30mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 9 months after pregnancy diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HRA Pharma

Investigators

  • Principal Investigator: Paul Fine, MD, Planned Parenthood Gulf Coast

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 18, 2014

Primary Completion (ACTUAL)

June 29, 2018

Study Completion (ACTUAL)

June 29, 2018

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (ESTIMATE)

April 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2914-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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