Breast FeedingNCT01465022
Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
A study testing Combined estrogen-progestin pill and Progestin-only pill in people with Breast Feeding and Contraception, run by University of New Mexico.
Trial summary
Objectives To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions: 1. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Contraception
- What is being tested?
- Combined estrogen-progestin pill and Progestin-only pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jun 2008
- Phase
- Interventional
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- able to give informed consent
- postpartum women delivering at the University of New Mexico Hospital
- Intend to breastfeed
- Plan to use oral contraceptives as her family planning method
- Willing to be randomized to either progestin-only pills or combined pills
Who cannot join
- medical contraindications to combined pills including history of thromboembolism, uncontrolled hypertension or complex migraine headaches
- preterm birth (<37 weeks)
- small for gestational age infant (<2500 grams)
- large for gestational age infant (>4500 grams)
- infant with major congenital anomaly
About this study
Objectives
To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:
Read more
- To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
- To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills.
- To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
Hypothesis
Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.
- Conditions
- Breast Feeding, Contraception
- Being tested
- Combined estrogen-progestin pill, Progestin-only pill
- Keywords
- Breastfeeding rates, Contraceptive continuation, Birth control pills, Lactation
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined estrogen-progestin pillDrug
Also called OCP
1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
Progestin-only pillDrug
Also called POP
.35 mg norethindrone once a day orally
| Study group | Role | What they receive |
|---|---|---|
| Study Arm A | Active comparator | Study Arm A is one of two interventions (Combined estrogen-progestin pill) Receives: Drug: Combined estrogen-progestin pill |
| Study Arm B | Active comparator | Study Arm B is one of two interventions (Progestin-only pill) Receives: Drug: Progestin-only pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Continued to Breastfeed at 6 Months
Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery
Measured: Baseline to Week 8, Week 8, 2-6 months
Secondary outcomes (4)
Number of Participants Who Continued Birth Control Method After 6 Months
Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery
Measured: Baseline to Week 8, Week 8, 2-6 months
Infant Length Growth From 2-8 Weeks
Comparison of infant length at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.
Measured: Week 2 and Week 8
Infant Weight Growth From 2-8 Weeks
Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.
Measured: Week 2 and Week 8
Infant Occipitofrontal Circumference Growth From 2-8 Weeks
Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.
Measured: Week 2 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startJan 2005
- Primary completionJun 2008
- Study completionJun 2008
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 Breast FeedingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists
- Responsible party
- Principal investigator, Eve Espey, University of New Mexico
- Investigators
- Eve Espey, MD, Principal investigator, UNM OB Gyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465022
- Sponsor's protocol ID
- 03-151
- Status last verified
- Feb 2016
- First submitted
- 1 Nov 2011
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Espey E, Ogburn T, Leeman L, Singh R, Ostrom K, Schrader R. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):5-13. doi: 10.1097/AOG.0b013e31823dc015.
PubMed 22143258
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01465022
- Acronym / sponsor ID
- 03-151
- Conditions
- Breast Feeding, Contraception
- Keywords
- Breastfeeding rates, Contraceptive continuation, Birth control pills, Lactation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists
- Study start
- Jan 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Posted 15 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives
To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:
- To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
- To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills.
- To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
Hypothesis
Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm A | Active comparator | Drug: Combined estrogen-progestin pillStudy Arm A is one of two interventions (Combined estrogen-progestin pill) |
| Study Arm B | Active comparator | Drug: Progestin-only pillStudy Arm B is one of two interventions (Progestin-only pill) |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- able to give informed consent
- postpartum women delivering at the University of New Mexico Hospital
- Intend to breastfeed
- Plan to use oral contraceptives as her family planning method
- Willing to be randomized to either progestin-only pills or combined pills
Key exclusion criteria (5 listed)
- medical contraindications to combined pills including history of thromboembolism, uncontrolled hypertension or complex migraine headaches
- preterm birth (<37 weeks)
- small for gestational age infant (<2500 grams)
- large for gestational age infant (>4500 grams)
- infant with major congenital anomaly
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 |
|---|---|---|
| Combined estrogen-progestin pillAlso: OCP1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo | Drug | Study Arm A |
| Progestin-only pillAlso: POP.35 mg norethindrone once a day orally | Drug | Study Arm B |
Primary outcome
Number of Participants Who Continued to Breastfeed at 6 Months
Time frame: Baseline to Week 8, Week 8, 2-6 months
Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery
4 secondary outcomes
Number of Participants Who Continued Birth Control Method After 6 Months
Time frame: Baseline to Week 8, Week 8, 2-6 months
Infant Length Growth From 2-8 Weeks
Time frame: Week 2 and Week 8
Infant Weight Growth From 2-8 Weeks
Time frame: Week 2 and Week 8
Infant Occipitofrontal Circumference Growth From 2-8 Weeks
Time frame: Week 2 and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22143258Espey E, Ogburn T, Leeman L, Singh R, Ostrom K, Schrader R. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):5-13. doi: 10.1097/AOG.0b013e31823dc015.
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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.
Eve Espey, MD principal investigator
UNM OB Gyn
Questions about this trial
What is this clinical trial studying?
A study testing Combined estrogen-progestin pill and Progestin-only pill in people with Breast Feeding and Contraception, run by University of New Mexico.
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 5 inclusion and 5 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2016). 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?
Number of Participants Who Continued to Breastfeed at 6 Months (time frame: Baseline to Week 8, Week 8, 2-6 months). 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 NCT01465022, 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 20 May 2016.