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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Milena Bastos Brito, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00828542
First received: January 23, 2009
Last updated: May 1, 2017
Last verified: May 2017
  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
Breastfeeding Contraception Drug: etonogestrel implant Drug: depot medroxyprogesterone acetate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 Milena Bastos Brito, MD, PhD, University of Sao Paulo:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


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
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 Name: 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 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   (Adult)
Sexes 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 (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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Milena Bastos Brito, MD, PhD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00828542     History of Changes
Other Study ID Numbers: HCRP4432/2007
Study First Received: January 23, 2009
Results First Received: June 12, 2012
Last Updated: May 1, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Milena Bastos Brito, MD, PhD, University of Sao Paulo:
Adverse Effects
Etonogestrel
Postpartum period
Contraception
Hemostasis
Metabolism

Additional relevant MeSH terms:
Etonogestrel
Desogestrel
Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 27, 2017