NCT01666912

Brief Summary

This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

August 14, 2012

Results QC Date

January 13, 2017

Last Update Submit

March 20, 2017

Conditions

AdolescenceContraceptionPostpartum

Keywords

adolescencecontraceptionpostpartumrapid repeat pregnancy

Outcome Measures

Primary Outcomes (1)

  • Continuation at 1 Year

    The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.

    12-14 months

Secondary Outcomes (2)

  • Satisfaction

    12 months

  • Rapid Repeat Pregnancy

    12 months

Study Arms (2)

6 week postpartum contraceptive implant

ACTIVE COMPARATOR

randomized to receive contraceptive implant at normal 6 week postpartum visit

Drug: Contraceptive implant

Immediate postpartum contraceptive implant

EXPERIMENTAL

randomized to receive contraceptive implant prior to leaving the hospital postpartum

Drug: Contraceptive implant

Interventions

Contraceptive implantDRUG
Also known as: Implanon, Nexplanon, etonogestrel contraceptive implant
6 week postpartum contraceptive implantImmediate postpartum contraceptive implant

Eligibility Criteria

Age14 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents ages 14-24 attending prenatal care
  • Greater than 20 weeks estimated gestational age
  • English or Spanish-speaking
  • Desire to use the contraceptive implant for contraception postpartum
  • Anticipated delivery of a healthy infant vaginally or by cesarean.

You may not qualify if:

  • Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including
  • current or past history of thrombosis or thromboembolic disorders
  • hepatic tumors (benign or malignant)
  • active liver disease
  • undiagnosed abnormal genital bleeding
  • known or suspected carcinoma of the breast (or a personal history of breast cancer)
  • hypersensitivity to any of the components of the contraceptive implant.
  • Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate
  • Characteristics that would preclude involvement after delivery:
  • Birth of a stillborn infant.
  • Maternal ICU admission after delivery
  • Maternal postpartum hemorrhage requiring blood transfusion
  • Prolonged hospital stay (\>7 days) postpartum
  • Coagulopathy associated with the pregnancy
  • Severe pregnancy-induced hypertension
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Contraceptive Agentsetonogestrel

Intervention Hierarchy (Ancestors)

Reproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Results Point of Contact

Title
Amy G. Bryant, Assistant Professor
Organization
UNC_ChapelHill
amy_bryant@med.unc.edu
919-843-5633

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 16, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 1, 2017

Results First Posted

May 1, 2017

Record last verified: 2017-03

Locations

US(1)