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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828542
• Other study ID #: HCRP4432/2007
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: January 23, 2009
• Start date: July 2007
• Est. completion date: February 2008

Study information

• Verified date: January 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contraception
• Postpartum Period

Intervention

Drug:
• etonogestrel-releasing implant
Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum)
• depot medroxyprogesterone
150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 weeks	Yes
Secondary	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		12 weeks	Yes