Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply
Brief Summary: The purpose of this pilot randomized trial is to determine the effectiveness, feasibility, and acceptability of a mobile, semi-automated text message-based intervention (MILK) to prevent perceived low or insufficient milk supply (PIM) among mothers without prior breastfeeding experience. PIM is the leading cause of premature breastfeeding cessation, and prior work shows that it is often rooted in low breastfeeding self-efficacy and misconceptions about lactation physiology and trajectory. The MILK intervention is designed to address PIM, as well as other common breastfeeding problems via semi-automated text messages of prenatal and postpartum breastfeeding education and support. Messages are time-sensitive (e.g., specific to gestational age, time since delivery) and based on the Breastfeeding Self-Efficacy (Social Cognitive) Theory; they are also modeled from pilot work that investigated how first-time mothers view, manage and describe breastfeeding problems. Messages were vetted with clinical lactation experts, as well as pregnant and postpartum women with no other children.

The MILK intervention will be trialed against a control intervention group, who will receive general perinatal education through the national Text4Baby system. The investigators will recruit approximately 186 healthy, pregnant women at 13-25 weeks gestation from Magee Women's Hospital clinics and outpatient sites. Women will be randomized via computer-generated simple randomization to the experimental or control intervention. Both groups will receive text messages 3-5 times per week from week 25 of pregnancy through week 8 postpartum. Measured outcomes of interest will include perceived breast milk supply, breastfeeding confidence, maternal anxiety, breastfeeding exclusivity, and breastfeeding duration. Data will be collected at baseline (13-25 gestational weeks), 34-36 gestational weeks, and at 1, 2, 4, and 8 weeks postpartum via online survey or telephone call. To assess the potential longer-term impact of the intervention, breastfeeding continuation and exclusivity will be reassessed via telephone at 6 months postpartum. Between group and group x time differences in outcome measures will be examined graphically and via linear mixed modeling. To inform modifications to MILK, telephone interviews will be conducted with a subset of participants in each group to assess and compare intervention use, burdens and challenges, and suggested alterations (8 weeks).


Options:
A: Inclusion Criteria:

* Pregnant women living in the study area

Exclusion Criteria:

* Unwilling to participate
B: Inclusion Criteria:

* Mothers of infants admitted during the study period with hyperbilirubinemia, breastfeeding at the time of admission (any amount of breastfeeding)
* Mothers of infants \< 1 month of age at the time of admission

Exclusion Criteria:

* Mothers of infants admitted with hyperbilirubinemia who are exclusively formula-fed
* Mothers of infants with hyperbilirubinemia of the predominantly conjugated type as this is a different disease, not associated with breastfeeding difficulties
* Mothers of infants with anatomical abnormalities, such as cleft lip or palate, as this would interfere with breastfeeding and require more intensive intervention.
* Mothers of neurologically impaired infants as breastfeeding may be more difficult in this population
* Mother of infants who were admitted to the Neonatal Intensive Care Unit (NICU) after birth and never went home as they are likely to have other comorbidities affecting feeding.
* Mothers of infants feeding via naso-gastric, naso-jejunal, or gastric tube
* Mothers of infants \> 1 month of age
* Mothers who have had breast surgery in the past
* Foster mothers or adoptive mothers
* Mothers who do not understand English or French
* Mothers of infants that are the result of multiple birth (eg twins)
C: Inclusion Criteria:

Pregnant women who:

1. are ≥ 18 years;
2. are between 13-25 gestational weeks;
3. have no prior breastfeeding experience or other living biological children;
4. have a personal cell phone with internet access and an unlimited text message plan; and
5. intend to exclusively, or nearly exclusively breastfeed (\<2 ounces of artificial milk per day) for at least 2 months postpartum; (6) plan to deliver their infant at MWH.

Exclusion Criteria:

1. Maternal, fetal, or neonatal conditions or complications with the potential to physiologically compromise breastfeeding or milk supply (e.g., history of breast reduction surgery, infant cardiac defects, postpartum infant ventilator dependence);
2. current gestation of ≥ 1 fetus;
3. contraindications to breastfeeding as specified by the American Academy of Pediatrics (e.g., HIV+ status).
D: Inclusion Criteria:

* Mothers booked for delivery in Dunedin, New Zealand

Exclusion Criteria:

* Women booked after 34 weeks gestation,
* Identified congenital abnormality likely to affect feeding and/or growth
* Home address outside of metropolitan Dunedin or Invercargill,
* Families who are likely to shift out of metropolitan Dunedin or Invercargill in the next 2 years.
* Unable to communicate in English or te reo Maori.

Answer: C