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

NCT ID: NCT00828542

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-02-29

Brief Summary

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

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.

Conditions

Breastfeeding; Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

etonogestrel implant

Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is compounded by 68mg of etonogestrel, 3years of duration.

Group Type: EXPERIMENTAL

etonogestrel implant

Intervention Type: DRUG

Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum)

depot medroxyprogesterone acetate

At the 6th week postpartum, this group received intramuscular 150 mg of depot medroxyprogesterone acetate (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil).

Group Type: ACTIVE_COMPARATOR

depot medroxyprogesterone acetate

Intervention Type: DRUG

150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery

Interventions

etonogestrel implant

Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum)

Intervention Type: DRUG

depot medroxyprogesterone acetate

150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery

Intervention Type: DRUG

Other Intervention Names

Implanon, Etonogestrel implant; medroxyprogesterone

Eligibility Criteria

Inclusion Criteria

• age between 18 and 35 years
• Postpartum contraception desire

Exclusion Criteria

• smoking, alcoholism or drug addiction
• presence of systemic diseases (diabetis melittus, cardiovascular disease, 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Milena Bastos Brito, MD, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolina S Vieira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Milena B Brito, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.

Reference Type: RESULT

PMID: 19913145 (View on PubMed)

Brito MB, Ferriani RA, Meijers JC, Garcia AA, Quintana SM, Silva de Sa MF, Vieira CS. Effects of the etonogestrel-releasing contraceptive implant inserted immediately postpartum on maternal hemostasis: a randomized controlled trial. Thromb Res. 2012 Sep;130(3):355-60. doi: 10.1016/j.thromres.2012.03.029. Epub 2012 Apr 28.

Reference Type: RESULT

PMID: 22542366 (View on PubMed)

Other Identifiers

HCRP4432/2007

Identifier Type: -

Identifier Source: org_study_id