Progestin-Only Pill Use and Breastfeeding Study

Study Overview
=================
Brief Summary
-----------------
This study will assess the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills (POPs) on maternal, breastmilk, and infant outcomes.

Detailed Description
-----------------
This is a placebo-controlled randomized controlled trial enrolling dyads of mothers and their newborn babies. We will explore if the type and timing of initiation of pills is acceptable to the user with minimal side effects, impacts the supply or composition of breastmilk, and/or affects infant growth. Women will be randomly assigned to 1 of 3 groups and will be blinded to group assignment: immediate initiation of drospirenone-containing progestin-only pills (d-POPs), immediate initiation of norethindrone-containing progestin-only pills (n-POPs) immediate initiation of a placebo pill for one month followed by d-POPs.

Official Title
-----------------
Progestin-Only Pill Use and Breastfeeding Study

Conditions
-----------------
Contraception, Breastfeeding

Intervention / Treatment
-----------------
* Drug: Progestin Only Contraceptive Pills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13 years of age and older Desires to use POPs for 3 months Speak English or Spanish Had a vaginal or cesarean delivery of a singleton full term (≥37 weeks) infant less than 168 hours prior Intends to breastfeed exclusively for 6 months Exclusion Criteria: Desire another pregnancy in less than 6 months Do not intend to exclusively breastfeed Do not have access to a telephone Have any medical contraindication to POPs Have any contraindication to breastfeeding, including maternal illegal drug use, history of augmentation or reduction, infant with major congenital anomaly Cognitively impaired Currently incarcerated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Initiation d-POPs<br>Initiation of d-POPs 120-160 hours after delivery. Dosing is 4mg daily for 24 days followed by 4 daily inactive tablets for 2 months. | Drug: Progestin Only Contraceptive Pills<br>* Daily pill (placebo or active tablet)<br>* Other names: Errin;|
| Experimental: Early Initiation n-POPs<br>Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months. | Drug: Progestin Only Contraceptive Pills<br>* Daily pill (placebo or active tablet)<br>* Other names: Errin;|
| Placebo Comparator: Interval Initiation of d-POPs<br>Placebo starting 120-160 hours after delivery, continuing for 28 days. Followed by 24 days of 4mg daily of d-POPs and 4 daily inactive tablets. | Drug: Progestin Only Contraceptive Pills<br>* Daily pill (placebo or active tablet)<br>* Other names: Errin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants exclusively breastfeeding at 2 months postpartum | Exclusive breastfeeding will be assessed at 8 weeks postpartum through an email self-reported survey. Type of infant feeding will be collected weekly beginning with enrollment to ascertain the length of time exclusively breastfeeding and date of stopping if applicable. | 8 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding supplementation type | If not exclusively breastfeeding, type of supplementation will be collected via text and email surveys. | Weeks 2-8 postpartum | 
| Proportion of participants using progestin-only pills at 2 months postpartum | Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey. | 8 weeks postpartum | 
| Vaginal bleeding | Number of days of any bleeding and spotting in last month will be collected via self-reported email survey. | 4 and 8 weeks postpartum | 
| Satisfaction with contraception method | Overall satisfaction and if participants would recommend the current method of contraception they are using to a friend will be ascertained from an email self-report survey. | 4 and 8 weeks postpartum | 
| Protein content of breastmilk | Mid-feeding breastmilk samples will be collected and analyzed. | 4 weeks postpartum | 
| Carbohydrate content of breastmilk | Mid-feeding breastmilk samples will be collected and analyzed. | 4 weeks postpartum | 
| Fat content of breastmilk | Mid-feeding breastmilk samples will be collected and analyzed. | 4 weeks postpartum | 
| Maternal perception of milk supply | Self-reported perception of adequacy of breastmilk supply will be collected with the 20-item Hill and Humenick Lactation Scale. Minimum scale score is 20 and maximum is 140, with higher scores representing a more positive perception of breastfeeding. | 4 and 8 weeks postpartum | 
| Change in infant weight | Weight in grams will be compared over 4 weeks. | Baseline and 4 weeks after delivery | 
| Change in infant height | Length as measured on a marked board to the nearest millimeter will be compared over 4 weeks. | Baseline and 4 weeks after delivery | 
| Change in infant head circumference | The maximum diameter through the glabella and occiput is found and measured with a tape measure and recorded to the nearest millimeter and compared over 4 weeks. | Baseline and 4 weeks after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minipill, Progestin-only Pill, Postpartum, Slynd, Camila, Micronor, Infant growth, Breastmilk, Drospirenone, Norethindrone