Complications; ContraceptivePhase 4NCT00847587
Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
A Phase 4 study testing Etonogestrel contraceptive implant in people with Complications; Contraceptive and Female Lactation, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications; Contraceptive, Female Lactation
- What is being tested?
- Etonogestrel contraceptive implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- obstetric complications including anemia with hematocrit<30,
- transfusion,
- infection,
- severe pregnancy induced hypertension,
- prolonged hospitalization,
- coagulopathy,
Show all 10Show fewer
- liver disease,
- undiagnosed genital bleeding,
- or other relative contraindication to Implanon® insertion (known or suspected pregnancy, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in Implanon®).
- Women taking drugs that are potent inducers of hepatic enzymes will also be excluded, including barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, modafinil, protease inhibitors, and herbal products including St. John's Wort.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital
Salt Lake City, Utah, 84105
About this study
Official title: Randomized Controlled Trial of 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 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.
Read the detailed description
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.
- Conditions
- Complications; Contraceptive, Female Lactation
- Being tested
- Etonogestrel contraceptive implant
- Keywords
- Contraceptive, Implant, Postpartum period, etonogestrel-releasing, lactogenesis, Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel contraceptive implantDrug
Implant insertion postpartum prior to hospital discharge
Etonogestrel contraceptive implantDrug
Standard insertion at 4-8 weeks postpartum
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Early postpartum insertion Receives: Drug: Etonogestrel contraceptive implant |
| 2 | Active comparator | Standard postpartum insertion Receives: Drug: Etonogestrel contraceptive implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days postpartum
Secondary outcomes (1)
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.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications; ContraceptiveStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Turok, University of Utah
- Investigators
- Shawn E Gurtcheff, MD, Principal investigator, University of UtahDavid K Turok, MD, Study chair, University of UtahKirtly P Jones, MD, Study director, University of UtahPatricia Murphy, DrPH, Study director, University of UtahSara E Simonsen, RN, BSN, Study director, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847587
- Sponsor's protocol ID
- 30291
- Status last verified
- Mar 2016
- First submitted
- 18 Feb 2009
- Last updated
- 18 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gurtcheff SE, Turok DK, Stoddard G, Murphy PA, Gibson M, Jones KP. Lactogenesis after early postpartum use of the contraceptive implant: a randomized controlled trial. Obstet Gynecol. 2011 May;117(5):1114-1121. doi: 10.1097/AOG.0b013e3182165ee8.
PubMed 21508750
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
- ClinicalTrials.gov ID
- NCT00847587
- Acronym / sponsor ID
- 30291
- Conditions
- Complications; Contraceptive, Female Lactation
- Keywords
- Contraceptive, Implant, Postpartum period, etonogestrel-releasing, lactogenesis, Breastfeeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 2 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Etonogestrel contraceptive implantEarly postpartum insertion |
| 2 | Active comparator | Drug: Etonogestrel contraceptive implantStandard postpartum insertion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- obstetric complications including anemia with hematocrit<30,
- transfusion,
- infection,
- severe pregnancy induced hypertension,
- prolonged hospitalization,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel contraceptive implantImplant insertion postpartum prior to hospital discharge | Drug | 1 |
| Etonogestrel contraceptive implantStandard insertion at 4-8 weeks postpartum | Drug | 2 |
Primary outcome
Time to Lactogenesis Stage II
Time frame: 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.
1 secondary outcome
Crematocrit of Human Milk
Time frame: 6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21508750Gurtcheff SE, Turok DK, Stoddard G, Murphy PA, Gibson M, Jones KP. Lactogenesis after early postpartum use of the contraceptive implant: a randomized controlled trial. Obstet Gynecol. 2011 May;117(5):1114-1121. doi: 10.1097/AOG.0b013e3182165ee8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn E Gurtcheff, MD principal investigator
University of Utah
David K Turok, MD study chair
University of Utah
Kirtly P Jones, MD study director
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etonogestrel contraceptive implant in people with Complications; Contraceptive and Female Lactation, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Lactogenesis Stage II (time frame: 5 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00847587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.