Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial

NCT ID: NCT04012177

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1884 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2023-12-31

Brief Summary

This four arm trial envisions to generate robust evidence for use of a fortified balanced energy-protein supplement to pregnant women for at least 6 months, alone versus in combination of Azithromycin (AZM) prophylaxis (two prophylaxis oral doses) versus in combination with both AZM prophylaxis (two prophylaxis oral doses) plus oral Choline and Nicotinamide supplementation; to see the impact on birth weight and length of newborn soon after birth (approximately within 72 hours). This is an open label, community-based, randomized controlled trial in peri-urban settings of Karachi, Pakistan, where the outcome assessor will be blinded. The comparison groups are control arm (only routine ANC care and nutritional counseling), nutrition only arm, nutrition plus AZM arm, and nutrition plus Choline and Nicotinamide arm.

Detailed Description

Maternal under nutrition has a critical role in etiology of poor perinatal outcomes like low birth weight (LBW), accounting for 60-80% of all neonatal deaths and impacting nearly 20 million newborns overall. In Pakistan, nearly half of the households are food insecure with or without hunger. Great disparities exist between urban-rural and within urban disadvantaged populations living in the poorest of slums. In Sindh province alone, 72% of households are food insecure and 50% are with moderate to severe hunger. Around 18% of the married woman of reproductive age in Pakistan, are underweight and deficient of different micronutrients for example, 42% and 41% of women are Vitamin A and Zinc deficient, respectively.. This impacts childhood stunting, wasting, and underweight, prevalence of which, among under-five children is around 44%, 15% and 31%, respectively in Pakistan. WHO antenatal care (ANC) guidelines recommend the use of fortified balanced energy-protein supplements during pregnancy, but there is a lack of guidance on the best product/supplement for use in a particular setting. Until recently, the WHO ANC guidelines has made no recommendations on the use of these supplements in food insecure and undernourished settings. This is an area that required further research. Additionally, there is emerging literature on use of Choline and Nicotinamide during pregnancy and its potential additional impact on birth outcomes including growth and development after prenatal supplementation with Choline and Nicotinamide.

Apart from nutrition supplement, the prophylaxis use of antibiotics, especially AZM is also under strong debate, as many studies have shown improvements in birth outcomes in low middle income settings. The possible mechanism of AZM may be explained through reduction in the risk of maternal infections during pregnancy. A systematic review showed that prophylaxis may reduce the risk of postpartum endometritis, preterm rupture of membranes and gonococcal infection when given routinely to all pregnant women With no effect on birth outcome but there were several biases reported such as high loss to follow-ups and limited numbers of included studies.. Therefore, robust evidence is needed via a field trial in the local context to evaluate the efficacy and effectiveness of the locally-produced, balanced energy-protein supplement alone or in combination with prophylaxis dose of AZM or balanced energy-protein supplement alone or in combination with Choline and Nicotinamide to pregnant woman on maternal and birth outcomes in low-income and food insecure settings. This could help to draw inferences for larger public health policy-making. This investment is specifically aiming to look at what impact a newly formulated nutritional supplement for pregnant and lactating women (PLW) can have on improving birth outcomes and as well as its potential to reduce wasting, stunting and underweight in infants.

Conditions

Undernutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Arm

Arm-A: Standard antenatal care (ANC) counseling, service provision and nutrition counseling (World Health Organization (WHO) standard)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nutrition only Arm

Arm-B:Balanced-energy protein (BEP), ready-to-use utrition supplement for at least 6 months + Standard ANC counseling, service provision and nutrition counseling (WHO standard)

Group Type: EXPERIMENTAL

Balanced-energy protein (BEP)

Intervention Type: DIETARY_SUPPLEMENT

Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.

Nutrition plus Azithromycin Arm

Arm-C:Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + 2000 mg of Azithromycin at week 20 and 28 of pregnancy + Standard ANC counseling, service provision and nutrition counseling (WHO standard).

Group Type: EXPERIMENTAL

Balanced-energy protein (BEP)

Intervention Type: DIETARY_SUPPLEMENT

Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.

Azithromycin Tablets

Intervention Type: DRUG

Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.

Nutrition plus Choline and Nicotinamide Arm

Arm-D: Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + Choline 450 and Nicotinamide 100 mg (1 each once daily orally starting from week 20 until birth outcome) + Standard ANC counseling, service provision and nutrition counseling (WHO standard).

Group Type: EXPERIMENTAL

Balanced-energy protein (BEP)

Intervention Type: DIETARY_SUPPLEMENT

Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.

Azithromycin Tablets

Intervention Type: DRUG

Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.

Choline Bitartrate

Intervention Type: DRUG

Pregnant women randomized in Arm D will received 450 mg of Choline orally once daily, starting from week 20 weeks of pregnancy until birth outcome

Nicotinamide

Intervention Type: DRUG

Pregnant women randomized in Arm D will received 100 mg of Nicotinamide orally once daily, starting from week 20 weeks of pregnancy until birth outcome

Interventions

Balanced-energy protein (BEP)

Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.

Intervention Type: DIETARY_SUPPLEMENT

Azithromycin Tablets

Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.

Intervention Type: DRUG

Choline Bitartrate

Pregnant women randomized in Arm D will received 450 mg of Choline orally once daily, starting from week 20 weeks of pregnancy until birth outcome

Intervention Type: DRUG

Nicotinamide

Pregnant women randomized in Arm D will received 100 mg of Nicotinamide orally once daily, starting from week 20 weeks of pregnancy until birth outcome

Intervention Type: DRUG

Other Intervention Names

Ready-to-use-supplementary food (RUSF); Zetro; Choline

Eligibility Criteria

Inclusion Criteria

• Gestational age between ≥8 and < 19 weeks confirmed by ultrasound
• Able to give written voluntary informed consent.
• Permanent resident within the surveillance area, i.e. woman should be resident of the area for last 6 months at least to be considered as part of surveillance.
• Willing to spend the whole pregnancy duration after registration in trial within surveillance area until the birth outcome.
• Singleton and viable fetus on ultrasound
• Not working woman, and available for ANC and compliance visits at home.
• Previously not enrolled in pregnant woman trial.
• Previously not enrolled in Lactating woman trials.

Exclusion Criteria

• Having Mid-upper-arm-circumference of pregnant of ≥30.5 cm
• Having known food allergies if reported by woman (like peanut, lentils)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University

OTHER

Sponsor Role: collaborator

Vital Pakistan Trust

OTHER

Sponsor Role: lead

Responsible Party

Yasir Shafiq

Senior Manager, Research and Programs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasir Shafiq, MSc

Role: PRINCIPAL_INVESTIGATOR

Vital Pakistan Trust

Ameer Muhammad, MSc

Role: PRINCIPAL_INVESTIGATOR

Vital Pakistan Trust

Fyezah Jehan, MSc

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Muhammad Imran Nisar, MSc

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Peri-urban slum (Rehri Goth)

Karachi, Sindh, Pakistan

Countries

Pakistan

References

Muhammad A, Fazal ZZ, Baloch B, Nisar I, Jehan F, Shafiq Y. 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). Trials. 2022 Jan 3;23(1):2. doi: 10.1186/s13063-021-05960-9.

Reference Type: DERIVED

PMID: 34980232 (View on PubMed)

Other Identifiers

004-VPT-IRB-18

Identifier Type: -

Identifier Source: org_study_id