Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan—a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial)

Muhammad, Ameer; Fazal, Zoha Zahid; Baloch, Benazir; Nisar, Imran; Jehan, Fyezah; Shafiq, Yasir

doi:10.1186/s13063-021-05960-9

Trials

Table 2 Time schedule of enrollment, interventions, and assessments

From: Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan—a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial)

Timepoints	T₀^a	Follow-ups collecting data on key study variables and indicators					Follow-ups for maternal anthropometry	Week 19	Week 32	Primary study endpoint	Extended follow-up Mother-infant dyad (Secondary study end points)
		Daily visits^b	48 hourly visits ^c	72 hourly visits ^d	Daily visits^e	Weekly^f	Week 23, 27, 31, 35, 39 of gestation			Primary study endpoint
		Daily visits^b	48 hourly visits ^c	72 hourly visits ^d	Daily visits^e	Weekly^f	Week 23, 27, 31, 35, 39 of gestation			At birth	1–2 months, 3–4 months, 5–6 months and 12 months
Enrollment
Eligibility assessment	×
Written informed consent	×
Randomization and allocation	×
Baseline data	×
Intervention
Nutrition counseling and ANC	×	×	×	×	×	×
BEP distribution and compliance assessment ^g	×	×	×	×	×	×
Oral Azithromycin administration at week 20 and 28 with daily follow-ups for SAEs monitoring after dose administration ^h					×
Follow-ups during pregnancy
24 h breastfeeding recall			×	×	×	×
Infant assessment for danger sign			×	×	×	×
24 h maternal food intake recall ⁱ						×
Monthly maternal anthropometry measurements performed by separate team (blinded from intervention details)							×				×
Maternal depression							×	×
Participant experience and rating different characteristics of BEP product ^g							×	×
Specimens’ collection during pregnancy
Maternal hemoglobin level ^j	×								×
Maternal ferritin level ^j	×								×
Maternal vitamin D level ^j	×								×
Maternal VAM blood collection ^j	×								×
Maternal urine collection for Choline metabolites ^k	×								×
Maternal plasma collection for proteomics ^k								×	×
Maternal plasma collection for Niacin metabolites ^k								×	×
Maternal stool collection
Birth outcome assessment
Newborn and maternal anthropometry measurements within 72 h of birth performed by separate team (blinded from intervention details)										×
Specimens’ collection soon after birth
Cord blood collection within 30 min of birth ^k										×
Breast milk collection within 72 h of birth ^k										×
Specimens’ collection during extended follow-up
Mother-infant dyad VAM blood collection ^k											×
Mother-infant dyad stool collection ^k											×
Infant’s growth and neurodevelopment assessment
Monthly infant and maternal anthropometry measurements performed by separate team (blinded from intervention details)											×
Neurodevelopment assessment using Mullen, HINE and GSED – at 6 and 12 months of infant’s age plus maternal depression ^l											×
MRI scan of infants ^k

^aWindow period for eligibility assessment and enrollment is 8–18.9 weeks of gestation
^bInitial 1–13 days from enrollment
^c15–25 days from enrollment
^d29–38 days from enrollment
^ePre- and post-Azithromycin administration, i.e., at weeks 20 and 28 of gestation
^f48 days from enrollment
^gOnly in intervention arm
^hOnly in intervention arm C and window period of 7 days
ⁱOnly monthly basis
^jAll participants who agreed
^kSub-sample of 50 in each arm

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ISSN: 1745-6215

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