Safety of the Etonogestrel-Releasing Implant During the Puerperium of Healthy Women

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00828542
First received: January 23, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.


Condition Intervention
Postpartum Period
Contraception
Drug: etonogestrel-releasing implant
Drug: depot medroxyprogesterone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety of the Etonogestrel-Releasing Implant During the Puerperium of Healthy Women

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • To assess the effects of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium on the hemostatic system of healthy women over a period of twelve weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to assess maternal (clinical and metabolic) and neonatal (clinical) safety data regarding the use of the etonogestrel implant during the immediate postpartum period and the first 12 weeks postpartum [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: etonogestrel implant Drug: etonogestrel-releasing implant
Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum)
Other Name: Implanon, Etonogestrel implant
Active Comparator: depot medroxyprogesterone Drug: depot medroxyprogesterone
150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery
Other Name: medroxyprogesterone

Detailed Description:

Many contraceptive methods are currently available. However, about 50% of all pregnancies in the world are not planned, most of them occurring in developing countries. Long-lasting reversible contraceptives such as the etonogestrel implant represent an option for the reduction of unwanted pregnancies, especially among patients at risk for a short intergestational period. In addition to preventing an undesired pregnancy, these methods have an impact on the reduction of the maternal-fetal morbidity-mortality known to be associated with these short intervals, also minimizing the malnutrition and the cycle of poverty caused by multiparity.

On the basis of inclusion and exclusion criteria, we will selected 40 puerperae aged 18 to 35 years at the Low Risk Prenatal Care Program of the University Hospital of Ribeirão Preto, University of São Paulo (HC-FMRP). The subjects will be randomized to two types of treatment (etonogestrel-releasing implant to be inserted 24 to 48 hours after delivery or 150 mg medroxyprogesterone administered every three months starting 6 weeks after delivery). Blood samples (40 mL) will be collected in a single procedure from these patients and stored for later determination of multiple hemostatic and metabolic variables at 24-48 hours and at 6 and 12 weeks after delivery. Data on maternal and neonatal clinical parameter will be also collected.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 18 and 35 years
  • Postpartum contraception desire

Exclusion Criteria:

  • smoking, alcoholism or drug addiction
  • presence of systemic diseases (DM2, CVD, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia)
  • having a body mass index ≥ 30 kg/m2
  • personal history of arterial or venous thrombosis
  • using any medication that might interfere with blood coagulation or with the assessment of haemostatic and inflammatory variables
  • presenting alterations in hepatic enzymes
  • being allergic to local anaesthetics (xylocaine)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828542

Locations
Brazil
University of Sao Paulo
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Carolina S Vieira, MD, PhD University of Sao Paulo
Principal Investigator: Milena B Brito, MD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Carolina Sales Vieira, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00828542     History of Changes
Other Study ID Numbers: HCRP4432/2007
Study First Received: January 23, 2009
Last Updated: January 23, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Adverse Effects
Etonogestrel
Postpartum period
Contraception
Hemostasis
Metabolism

Additional relevant MeSH terms:
Medroxyprogesterone
Desogestrel
Medroxyprogesterone Acetate
3-keto-desogestrel
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 17, 2014