Health Condition 1: O923- Agalactia
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy women between 20-40 years of age 2.Women with uncomplicated full-term delivery (vaginal or LSCS). 3.Women who have accomplished antenatal breastfeeding promotion protocol immediately postpartum or within three days of delivery. 4.Women able to understand the study requirements and can fill the study log diary, and follow other procedures required by the study protocol. 5.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1.Postpartum women with contraindications to breastfeeding, such as HIV, chemotherapeutic drugs, radioactive substances, and babies with galactosemia. 2.Postpartum women with unstable conditions (i.e., postpartum hemorrhage, sepsis). 3.Women with known allergies to Shatavari or oats, raisins, almonds, cocoa, and honey. 4.Women whose babies require phototherapy, women with insufficient glandular tissue or breast surgery and any structural abnormality of the breast. 5.Women with a history of infertility, hypothyroidism, women with twins, or higher-order births. 6.Any known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological, or neurological illnesses or the presence of any current psychiatric disorders in women will be considered as exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total volume (mL) of breast milk extracted by breast pump (manual/automatic)Timepoint: Baseline, 72 hrs., Week 2, Week 4, Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time (hours) to first evident noticeable breast fullness after deliveryTimepoint: Delivery to 72 hrs;Time (hours) to noticeable breast fullness after last feeding based on maternal perception recorded in diaryTimepoint: Week 2, Week 4, Week 6;Breastfeeding Self Efficacy Scale Short Form (BSES SF) scoresTimepoint: Day 3 (72 hours), Week 2, Week 4, Week 6;Frequency of breastfeeding/feeding sessions per 24 hours; documented in maternal diaryTimepoint: Week 2, Week 4, Week 6;Mean Edinburgh Postnatal Depression Scale (EPDS) scores; maternal psychological well being assessmentTimepoint: Day 3 (72 hours), Week 2, Week 4, Week 6;Nipple pain or trauma evaluated using Visual Analog Scale (VAS 0 10)Timepoint: Day 3 (72 hrs.), Week 2, Week 4, Week 6;Mean change in Infant body weight (weight gain) from birthTimepoint: Delivery, Day 3 (72 hrs.), Week 2, Week 4, Week 6;Infant outcomes including fussiness and stooling frequency; documented in maternal diaryTimepoint: Day 3 (72 hrs.), Week 2, Week 4, Week 6;Detection of Shatavari in breast milk samples in a subset of 5 10 participantsTimepoint: Week 2, Week 4, Week 6 | — |
Countries
India
Contacts
Public ContactDr Hemant Mandlik
Sukhakarta Hospital
Outcome results
None listed