Trial Outcomes & Findings for Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant (NCT NCT00847587)

Results Overview

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 the nearest hour.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

69 participants

Primary outcome timeframe

5 days postpartum

Results posted on

2016-04-18

Participant Flow

Participants were recruited in the postpartum ward of the University of Utah hospital. Recruitment took place during 2009-2010.

Randomization occurred after consent. No participants were excluded from the trial after randomization.

Participant milestones

Participant milestones
Measure	Early Postpartum Insertion Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.	Standard Postpartum Insertion Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
Overall Study STARTED	35	34
Overall Study COMPLETED	34	34
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Postpartum Insertion n=35 Participants Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.	Standard Postpartum Insertion n=34 Participants Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.	Total n=69 Participants Total of all reporting groups
Age, Continuous	27 years STANDARD_DEVIATION 6 • n=93 Participants	25 years STANDARD_DEVIATION 6 • n=4 Participants	26 years STANDARD_DEVIATION 6 • n=27 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	34 Participants n=4 Participants	69 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	35 participants n=93 Participants	34 participants n=4 Participants	69 participants n=27 Participants

PRIMARY outcome

Timeframe: 5 days postpartum

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 the nearest hour.

Outcome measures

Outcome measures
Measure	Early Postpartum Insertion n=35 Participants Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.	Standard Postpartum Insertion n=34 Participants Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
Time to Lactogenesis Stage II	64.3 hours Standard Deviation 19.6	65.2 hours Standard Deviation 18.2

SECONDARY outcome

Timeframe: 6 weeks postpartum

Population: Both intent-to-treat and per-protocol analyses were performed. Per-protocol analysis is presented to demonstrate the more conservative analysis for the primary outcomes in a noninferiority study.

Determination of creamatocrit is a simple method for estimating the fat \& energy content of human milk based on the centrifugation of milk in a hematocrit centrifuge. The method for creamatocrit measurement was as described by Lucas et al (LucasA, GibbsJA, LysterRL, BaumJD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. BritMedJnl1978;1:1018-20)using a standard hematocrit centrifuge, standard hematocrit glass capillary tube, \& vernier calipers. Measurements were performed in duplicate and the mean for each measurement used for analysis.

Outcome measures

Outcome measures
Measure	Early Postpartum Insertion n=21 Participants Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.	Standard Postpartum Insertion n=22 Participants Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
Crematocrit of Human Milk	7.5 Percent creamatocrit Standard Deviation 3	6.8 Percent creamatocrit Standard Deviation 3.2

Adverse Events

Early Postpartum Insertion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Postpartum Insertion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kirtly Parker Jones

UUtah

Phone: 801-581-3834

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place