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

May 1, 2017 updated by: Milena Bastos Brito, MD, PhD, University of Sao Paulo
The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • Brazil
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14049-900
        • University of Sao Paulo

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 to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

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

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: etonogestrel implant
Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum)
Other Names:
  • Implanon, Etonogestrel implant
ACTIVE_COMPARATOR: depot medroxyprogesterone acetate
At the 6th week postpartum, this group received intramuscular 150 mg of depot medroxyprogesterone acetate (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil).
Drug: depot medroxyprogesterone acetate
150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery
Other Names:
  • medroxyprogesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks
Time Frame: 12 weeks

Activated protein C (APC) resistance is the most important marker of coagulation system in women using hormonal contraceptive methods.

APC resistance was determined by testing the effect of APC on the endogenous thrombin potential (ETP) using the Calibrated Automated Thrombogram® (CAT) assay. The sensitivity ratio or APC (APCsr) of each plasma sample was determined in the presence or absence of approximately 4 nM APC (Enzyme Research Laboratories, Swansea, United Kingdom). The APC concentration was adjusted to maintain the residual thrombin generation activity in normal pooled plasma at approximately 10%. Normal pooled plasma was run in parallel on each plate.

The normalized ratio (nAPCsr) was determined by dividing the APCsr of an individual sample by the APCsr of the pooled plasma.

Thus, nAPCsr >1.0 indicated APC resistance.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal (Clinical and Metabolic) and Neonatal (Clinical) Safety Regarding the Use of the Etonogestrel Implant During the Immediate Postpartum Period and the First 12 Weeks Postpartum
Time Frame: 12 weeks
Evaluation during the immediate postpartum period was performed at the hospital 24-48 h after delivery, in the morning and after a 12-h fast. Women and newborns were both weighed (Kg), and the blood pressure (mmHg), waist circumference (WC) (cm) and height (m) of the women were each measured by the same observer. Peripheral blood samples (20 mL) were collected and processed within 2 h after being collected. After clotting the serum, samples were centrifuged at room temperature for 10 min, and the sera were stored at -80°C until they were used for the simultaneous determination of all variables except for the complete blood count, which was performed before clotting. The following variables were analyzed: fasting serum glucose; total cholesterol (TC), high density lipoprotein (HDL) cholesterol, and triglycerides (TG), and low density lipoprotein (LDL) cholesterol
12 weeks

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Milena B Brito, MD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2007

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (ESTIMATE)

January 26, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCRP4432/2007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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