Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

NCT01569737 | Completed Results DMC

• 1 other identifier: 2914-012
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergency Contraception

Keywords

ella; ulipristal acetate; pregnancy; emergency contraception

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ella

Drug: ella

Interventions

ella DRUG

ella, single intake, tablet 30mg

ella

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• HRA Pharma: lead

Study Sites (1)

Planned Parenthood Federation of America, Inc

New York, New York, 10001, United States

Location

MeSH Terms

Interventions

ulipristal acetate

Limitations and Caveats

This was an observational study only, thus we were limited to the outcomes reported.

Results Point of Contact

• Title: Christine Adelbrecht, Clinical Trial Coordinator
• Organization: HRA Pharma

c.adelbrecht@hra-pharma.com

+33 1 40 33 32 74

Study Officials

• Paul Fine, MD

  Planned Parenthood Gulf Coast

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 3, 2012
• Study Start: November 18, 2014
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-09

Locations

US (1)