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NCT00847587 · ClinicalTrials.gov registry record · Phase 4

Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

A Phase 4 study of Complications; Contraceptive and Female Lactation, sponsored by University of Utah.

Completed
Registry status
Phase 4
Development phase
69
Enrollment target
1
Study location

NCT00847587: Completed Phase 4 study of Complications; Contraceptive and Female Lactation, sponsored by University of Utah.

NCT00847587 is a Phase 4 study of Complications; Contraceptive and Female Lactation that has completed, run by University of Utah. The registered enrollment target is 69 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00847587, a Phase 4 study of Complications; Contraceptive and Female Lactation, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Phase 4
Development phase
69 participants
Enrollment target
1
Study location

Study Summary

A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side effects, time to resume sexual intercourse after delivery, and incidence of missed routine postpartum follow-up. In addition, a subset of patients who randomize to early postpartum insertion will have expressed breastmilk ascertained for nutrient composition.

Primary Outcome

The primary outcome, time to lactogenesis stage II in hours, was documented by maternal perception as previously described and validated in the literature. Subjects were asked, "Has your milk come in? Some women experience this as a prickly feeling or tingling in the breast, dripping from the other nipple when nursing, milk running from the baby's mouth, or gulping by the baby. " If the response was positive, subjects were then asked, "When did your milk come in?" and the response recorded to th

Interventions

  • DRUG Etonogestrel contraceptive implant

Study Locations (1)

Utah

  • University of Utah Hospital - Salt Lake City

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2009-01
Est. Completion 2010-05
Phase Phase 4
University of Utah

818 total trials

What the finished NCT00847587 record still lists

NCT00847587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).

The record links to 2 conditions, with Complications; Contraceptive appearing as the primary indexed condition, and to 1 intervention - of which Etonogestrel contraceptive implant is the first listed.

NCT00847587 reports a single indexed study location in Utah.

Frequently Asked Questions

What is clinical trial NCT00847587 about?

NCT00847587 is a clinical study titled "Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant". A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpa...

What is the current status of trial NCT00847587?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2009-01. Estimated completion is 2010-05.

What conditions does trial NCT00847587 study?

This clinical trial studies the following conditions: Complications; Contraceptive, Female Lactation.

What interventions are being tested in trial NCT00847587?

The interventions under investigation include: Etonogestrel contraceptive implant (DRUG).

Who is sponsoring clinical trial NCT00847587?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00847587 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00847587's enrollment target sits among peer trials

69 1070th of 2000 higher than 925 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00847587, the US trial registry maintained by the National Library of Medicine. NCT00847587 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.