- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: 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
Otros nombres:
|
Comparador activo: Study Arm B
Study Arm B is one of two interventions (Progestin-only pill)
|
.35 mg norethindrone once a day orally
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Who Continued to Breastfeed at 6 Months
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Who Continued Birth Control Method After 6 Months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eve Espey, MD, UNM OB Gyn
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 03-151
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