A Phase 4 interventional study of Etonogestrel contraceptive implant and Etonogestrel contraceptive implant in Complications; Contraceptive and Female Lactation, sponsored by University of Utah. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-18.
Sponsored by University of Utah · Phase 4, Interventional, and Treatment
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.
This is a randomized controlled trial. Participants will be assigned with equal probability to 1 of the 2 test groups using computer-generated random numbers in blocks of varying sizes. Allocation concealment will be assured by enclosing assignments in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened sequentially and only after the participant's name and study number are written on the envelope. Follow-up and data collection for participants in each group will be identical. Outcome assessors and data analysts will be blinded to treatment arm.
STUDY PROCEDURES:
Inclusion/exclusion criteria will be verified and consent obtained. The patient will be notified of the results of randomization and the physician able to perform insertion will be contacted to perform the insertion. All insertions will be performed by physicians who have completed Implanon® insertion training. If the patient randomizes to standard postpartum insertion, she will be given a clinic appointment in 4-8 weeks for the insertion procedure.
Lactogenesis time will be documented by maternal perception, as described and validated by Chapman et al16. If lactogenesis has not occurred prior to hospital discharge, the patient will receive daily phone calls from study personnel until lactogenesis can be confirmed and recorded. Contact information for the patient, as well as for two friends or relatives who will know how to reach her will be obtained and verified prior to discharge. Participants will be given a reminder card for the telephone calls from the investigator and a postpartum visit appointment. Patients will be instructed to contact the investigators immediately for pain, excessive bleeding, difficulty with breastfeeding, or other concerns. Patients will be given a log book ("diary") to record breastfeeding parameters including use of supplementation, infant weights, side effects, return to sexual intercourse, contraceptive method use, and days of bleeding for the study follow-up period.
Clinical follow-up will be as follows. Postpartum telephone calls or visits to collect additional data will occur as needed for up to 5 days following hospital discharge, at 2 weeks, 4-8 weeks, and 3 and 6 months postpartum. Information obtained at these points will include: breastfeeding status and parameters, collection of record of infant weights (birth, 4-8 weeks, and 6 months), reminders to keep weekly diary, collection of diaries (6 month visit), resumption of sexual activity, use of contraceptive method, and satisfaction with contraceptive method. Patients randomized to early insertion will be asked to give a milk sample for analysis at their 4-8 week visit. Table 1 describes the contact points with the subject for collection of data. Contact will be either by telephone or at clinic visits.
289 studies on the registry are indexed under Breast Feeding; 119 are open to participants now.
This study's enrollment of 69 is below the median of 97 across 228 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →University of Utah is the lead sponsor of 991 studies on the registry; 177 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 64 (58%) have results posted.
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Inclusion Criteria: Patients on the postpartum ward at University Hospital will be offered inclusion in the study if they are:
Exclusion Criteria:
Early postpartum insertion
Drug: Etonogestrel contraceptive implant
Standard postpartum insertion
Drug: Etonogestrel contraceptive implant
Implant insertion postpartum prior to hospital discharge
Standard insertion at 4-8 weeks postpartum
Time to Lactogenesis Stage II
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.
Time frame: 5 days postpartum
Crematocrit of Human Milk
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.
Time frame: 6 weeks postpartum
Participants were recruited in the postpartum ward of the University of Utah hospital. Recruitment took place during 2009-2010.
| Milestone | Early Postpartum Insertion | Standard Postpartum Insertion |
|---|---|---|
| Started | 35 | 34 |
| Completed | 34 | 34 |
| Not completed | 1 | 0 |
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.
| hours | Early Postpartum Insertion | Standard Postpartum Insertion |
|---|---|---|
| Time to Lactogenesis Stage II | 64.3 ± 19.6 | 65.2 ± 18.2 |
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.
| Percent creamatocrit | Early Postpartum Insertion | Standard Postpartum Insertion |
|---|---|---|
| Crematocrit of Human Milk | 7.5 ± 3 | 6.8 ± 3.2 |
Collected over Adverse event data was collected for 6 months from delivery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early Postpartum Insertion | — | 0/35 (0%) | 0/35 (0%) |
| Standard Postpartum Insertion | — | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(years) | Early Postpartum Insertion | Standard Postpartum Insertion | Total |
|---|---|---|---|
| Mean | 27 ± 6 | 25 ± 6 | 26 ± 6 |
| Sex: Female, Male(Participants) | Early Postpartum Insertion | Standard Postpartum Insertion | Total |
|---|---|---|---|
| Female | 35 | 34 | 69 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Early Postpartum Insertion | Standard Postpartum Insertion | Total |
|---|---|---|---|
| United States | 35 | 34 | 69 |
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