- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01465022
Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Study Arm A
Study Arm A is one of two interventions (Combined estrogen-progestin pill)
|
1 mg norethindrone and .035
mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
Andre navn:
|
Aktiv komparator: Study Arm B
Study Arm B is one of two interventions (Progestin-only pill)
|
.35 mg norethindrone once a day orally
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Who Continued to Breastfeed at 6 Months
Tidsramme: 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
|
Baseline to Week 8, Week 8, 2-6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Who Continued Birth Control Method After 6 Months
Tidsramme: Baseline to Week 8, Week 8, 2-6 months
|
Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery
|
Baseline to Week 8, Week 8, 2-6 months
|
Infant Length Growth From 2-8 Weeks
Tidsramme: Week 2 and Week 8
|
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.
|
Week 2 and Week 8
|
Infant Weight Growth From 2-8 Weeks
Tidsramme: Week 2 and Week 8
|
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.
|
Week 2 and Week 8
|
Infant Occipitofrontal Circumference Growth From 2-8 Weeks
Tidsramme: Week 2 and Week 8
|
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.
|
Week 2 and Week 8
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Eve Espey, MD, UNM OB Gyn
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 03-151
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .