Weight Gain, PregnancyMMiPNCT05108675
Microbiome and Malnutrition in Pregnancy (MMiP)
An observational study of Weight Gain, Pregnancy and Microbial Colonization, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Nutritional status during pregnancy plays an important role in maternal health and birth outcomes. While few factors impacting nutritional status during pregnancy have been identified, studies of undernutrition in children have revealed a key role for the gut microbiome. Read more about this study
- Who is it for?
- Ages 17 to 24 years, women only
- Conditions the study is for
- Weight Gain, Pregnancy, Microbial Colonization, Pregnancy Related
- How many people
- 400 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Nov 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: This study will examine young, married women ≤24 years living in Matiari District, Pakistan. The investigators focus on younger women, due to the lack of knowledge about their microbiome and their vulnerability to undernutrition
Who may be able to join
- Consent provided
- Married female aged 17-24 years
- In good general health, with no comorbidities
- Absence of COVID19 symptoms
- Intend to comply with study procedures and follow up
Who cannot join
- Women who do not meet the enrollment age criteria
- Women participating in interventional clinical trials
- Women who intend to leave the study area
- Women who cannot comply with study procedure's and follow-up
- Illness and other co-morbidities
- Signs of potential COVID19 infection
Show all 10Show fewer
- BMI higher than 24.9 kg/m2
- Women who already have a member of their household participating
- Women who have taken antibiotics within the past 3 months
- Women who are past 16 weeks post- conception
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Research and Training Centre Matiari, Aga Khan University
Karachi, Sindh, 74000
About this study
Official title: Elucidating the Dynamics and Impact of the Gut Microbiome on Maternal Nutritional Status During Pregnancy
Nutritional status during pregnancy plays an important role in maternal health and birth outcomes. While few factors impacting nutritional status during pregnancy have been identified, studies of undernutrition in children have revealed a key role for the gut microbiome. Remarkably, studies examining the dynamics of the maternal gut microbiome before and during pregnancy and its impact on birth outcomes are limited.
This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on married pregnant women 24 years and younger living in Matiari District in Pakistan. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. Investigators hypothesizes that alterations of the microbiota in the maternal gut (dysbiosis) is exacerbated by nutritional status or pathogen exposure during pregnancy. This impacts weight gain because of impaired nutrient absorption, and can lead to corresponding negative birth outcomes.
Read the detailed description
This project represents the first systematic investigation of the impact of the microbiome on nutritional status during pregnancy in young women and directly aligns with global health initiatives focused on this vulnerable cohort. The goal of the study is to define the relationships between host nutritional status and microbiome dynamics during pregnancy and how they contribute to birth outcomes. The gut microbiome has a profound influence on host nutritional status. Dysbiosis (loss of diversity/beneficial microbes and gain of pathobionts) has emerged as a major factor in the development of undernutrition. Despite the importance of nutrition during pregnancy, few studies have examined the role of the microbiome on maternal health and birth outcomes. Further, little is known concerning the influence of enteric eukaryotic microbes, such as parasites, on the bacterial microbiome and host nutrition.
At the core of this study are two complementary cohorts of young women that provide an exceptional opportunity to obtain longitudinal samples to monitor the dynamic relationships between microbiome community structure and function with gut health and host nutritional status. This registration is for the Matiari, Pakistan cohort of the study, where there is known to be a high prevalence of undernutrition among young women. This cohort is expected to yield insights into the influence of eukaryotic microbes that are often viewed as asymptomatic. The target demographic of the study is young, married mothers, ≤24 years in Matiari District within the province of Sindh, Pakistan. Matiari District is representative of rural settings in Pakistan The investigators have identified this younger demographic due to the lack of knowledge on the microbiome of young women, and their vulnerability to undernutrition. A second complementary cohort will be based Toronto, Canada. This project will yield insights into the relationships between prokaryotic and eukaryotic microbes in the gut and their associations with maternal health and birth outcomes.
The central hypothesis of the study is that alterations of the microbiota in the maternal gut (dysbiosis) exacerbated by nutritional status or pathogen exposure during pregnancy, impacts weight gain because of impaired nutrient absorption, leading to corresponding negative birth outcomes.
The study will be a prospective, longitudinal, observational study to investigate the impact and relationship between prokaryotic and eukaryotic microbes in the gut and their association with maternal health and birth outcomes among married young women ≤24 years residing in Matiari District. . The study will aim to recruit 400 women into two groups based on BMI at time of recruitment (normal BMI will be defined as between 20 and 24.9 kg/m2 and low BMI will be defined as less than 20 kg/m2). With a goal of having 200 participants within the normal BMI group and 200 participants within the low BMI group. Although this is the recruitment aim, in the event that the investigators are unable to recruit 200 women with a low BMI, more women will be recruited that fall within the normal BMI range. The study will follow women and their infants over the course of their pregnancy and for a year postpartum, collecting stool, rectal and blood samples, nutritional information, heath assessments, anthropometric measurements and empowerment metrics at different time points.
- Conditions
- Weight Gain, Pregnancy, Microbial Colonization, Pregnancy Related, Pregnancy Loss, Pregnancy Complications, Pregnancy; Parasitic Disease
- Keywords
- Maternal Malnutrition, Gut Dysbiosis, Infant Health
- Medical subject headings
- Gestational Weight Gain, Communicable Diseases, Pregnancy Complications, Parasitic Diseases, Infant Nutrition Disorders, Malnutrition, Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if alterations of the microbiota in the maternal gut (dysbiosis) are corelated with changes in maternal gestational weight gain
The primary endpoint will be the change in maternal gestational weight gain (GWG) during pregnancy, measured between the first (8-16 weeks post-conception) and second time point (30-34 weeks post-conception)
Measured: 8-20 weeks post-conception, 30-34 weeks post-conception
To determine the correlation between maternal microbiome dysbiosis during pregnancy and birth weight.
The primary endpoint will be change in birthweight measured in kilograms.
Measured: At birth
To determine the correlation between maternal microbiome dysbiosis during pregnancy and infant growth
The primary endpoint will be change in WHO z-scores during first year of infant's life. These z-scores will be calculated for weight (measured in kg), length and head circumference (measured in cm).
Measured: 3month, 6month and 12month postpartum
Secondary outcomes (56)
Anthropometrics
Maternal BMI
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, delivery, 3-months post-partum, 6 months post-partum and 12 months post-partum ]
Anthropometrics: Maternal middle upper arm circumference
Measured in cm
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum,and 12 months post-partum
Anthropometrics: Maternal triceps skinfold thickness
Measured in mm
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, and 12 months post-partum
Anthropometrics: Maternal height
measured in cm
Measured: 8-16 weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post partum
Anthropometrics: Maternal weight
measured in kg
Measured: 8-16weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post-partum
Maternal blood biomarker-1
Concentration of HB in g/dL, marker of anemia.
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-2
Level of MCV in whole blood measured in femtoliters (fL).
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-3
Concentration of Ferritin in serum measured in ng/mL, marker of iron stores in blood.
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-4
Concentration of CRP in blood, measured in mg/dL, marker of inflammation .
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Infant blood biomarker-1
Concentration of HB in g/dL, marker of anemia.
Measured: 1 year infant age
Infant blood biomarker-2
Level of MCV in whole blood measured in femtoliters (fL).
Measured: 1 year infant age
Infant blood biomarker-3
Concentration of Ferritin in serum measured in ng/mL, marker of iron stores in blood.
Measured: 1 year infant age
Infant blood biomarker-4
Concentration of CRP in blood, measured in mg/dL, marker of inflammation .
Measured: 1 year infant age
Infant sex
Male Female
Measured: At birth
Infant morbidity
Assessed through infant health assessment questionnaire
Measured: at 3 months, 6 months and 12 months
Maternal morbidity
Assessed through health assessment questionnaire
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, 3 months post-partum, 6 months post-partum and 12 months post-partum
Infant growth: weight
Measured in kg
Measured: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: length
Measured in cm
Measured: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: head circumference
Measured in cm
Measured: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: mid upper arm circumference
Measured in cm
Measured: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: triceps skinfold thickness
Measured in mm
Measured: within 72 hours of birth, 3 months, 6 months and 12 months
Gestational age at birth
Measured in weeks
Measured: Within 72 hours of birth
Maternal age
Age between 17-24 years documented through national ID card, school certificate or through maternal recall
Measured: 8-16 weeks post conception
Breast feeding
amount and initiation of breast feeding, top milk, formula milk and complementary feeding Based off of WHO 2010 Guidelines: Indicators for assessing infant and young child feeding practices (Part 2 Measurement)
Measured: at birth within 72 hours, 3 months, 6 months and 12 months
Reported Maternal medicinal use
Questionnaire
Measured: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, 6 months post-partum and 12 months post-partum
Reported Infant medication use
Questionnaire
Measured: at birth within 72 hours, 3 months, 6 months and 12 months
Maternal dietary intake Assessed through ASA 24 HR Dietary Recall system, completed 2x each time point
Assessed through ASA 24 HR Dietary Recall system
Measured: Baseline 8-16 weeks post conception, 30-34 weeks post conception and 12 months post partum
Dietary diversity
Minimum Dietary Diversity Score for Women (MDD-W)
Measured: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post-partum and 12 months post partum
Household annual food insecurity
Food insecurity will be assessed using the Household Food Insecurity Access Scale (HFIAS)
Measured: 3 months post-partum and 12 months post-partum
Generalized Self-efficacy
Self-efficacy will be measured using the Generalized Self-Efficacy scale, developed by Schwarzer and Jerusalem. A 10 item psychometric scale.
Measured: 3 months post-partum and 12 months post partum
Perceived decision making
Questions pertaining to perceived decision-making are from the Pakistan Demographic and Health Survey (PDHS)
Measured: 3 months post-partum and 12 months post partum
Perceived social support
Perceived social support will be measured using the Multi-dimensional Scale of Perceived Social Support (MSPSS), developed by Zimet et al.
Measured: 3 months post-partum and 12 months post partum
Maternal demographics
Questions pertaining to demographic data are adapted from the Pakistan Demographic and Health Survey (PDHS)
Measured: Baseline 8-16 weeks post-conception
Food insecurity
Questionnaire developed by Hager, E.R., et al., Development and validity of a 2-item screen to identify families at risk for food insecurity.
Measured: Baseline 8-16 weeks post conception, 3 months post partum and 12 months post partum
Perceived parental stress
Perceived parental stress will be measured using the Perceived Stress Scale (PSS-10)
Measured: 3 months post-partum and 12 months post partum
Preterm Births
Gestational age at birth in weeks
Measured: At birth within 72 hours
Small for gestational age
Small-for-gestational-age (<10th percentile of weight-for-gestational-age and sex as defined by Intergrowth standards)
Measured: At birth within 72 hours
Large for gestational age
>90th percentile of weight-for-gestational-age and sex as defined by Intergrowth standards)
Measured: At birth within 72 hours
Delivery Assessment
Questionnaire, mode of delivery, place of birth and other description around delivery
Measured: at birth within 72 hours of birth
Infant dietary intake
NutricheQ Questionnaire: a tool designed for toddlers aged 1 to 3 years of age, with a focus on markers for inadequate or excessive intake and dietary imbalances
Measured: Infant age 1 year
Maternal stool biomarkers-1
Level of Calprotectin in stool a marker of intestinal inflammation, measured in μg/g.
Measured: At baseline 8-16 weeks post conception and 30-34 weeks post conception
Maternal stool biomarkers-2
Concentration of Claudin 15 in stool a marker of intestinal permeability measured in ng/mL.
Measured: At baseline 8-16 weeks post conception, 30-34 weeks post conception
Maternal stool biomarkers-3
Concentration of Lipocalin in stool, a marker of gut inflammation, measured in μg/mL.
Measured: At baseline 8-16 weeks post conception and 30-34 weeks post conception
Maternal: incidence of pathobionts
As identified through 16S, 18S and ITS rDNA surveys
Measured: Baseline, 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant: incidence of pathobionts
As identified through 16S, 18S and ITS rDNA surveys
Measured: 3 and 12 month
Maternal: metabolomic profile of stool [Metabolites involved in central metabolism as analysed by Mass Specttrometry]
Analysis of the core metabolites involved in central metabolism. These metabolites will be analysed through Mass Spec and include short chain fatty acids, amino acids, intermediates in energy metabolism and nucleotide biosynthesis
Measured: Baseline, 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Maternal gut bacteria profile
Measured through 16S rDNA sequence surveys
Measured: Baseline, 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Maternal: blood metallomics profile
Measured through ICP-MS (https://www.metabolomicscentre.ca/new_service/25) - TMIC platform of metabolmics
Measured: Baseline, 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant: blood metallomics profile
as measured through ICP-MS (https://www.metabolomicscentre.ca/new_service/25) Through TMIC platform
Measured: Infant age 1 year
Infant: gut bacterial profile
Measured through 16S rDNA sequence surveys
Measured: 3 month and 12 month
Maternal metabolic pathway expression profile
as measured through whole microbiome RNASeq (metatranscriptomics)
Measured: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant eukaryotic microbiome profile
as measured through 18S and ITS rDNA sequence surveys
Measured: 3 & 12 Months
Maternal eukaryotic microbiome profile
as measured through 18S and ITS rDNA sequence surveys
Measured: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum ]
Maternal bacterial gene expression profile
as measured through whole microbiome RNASeq (metatranscriptomics) - The output of these analyses are readouts of microbial gene expression detailing biochemical activities as well as the taxa responsible.
Measured: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum ]
Maternal: microbiome taxonomic alpha and beta diversity
To define taxonomic diversity, species profiles from 16S, 18S and ITS rDNA data will be clustered to identify differences in community structure across samples. Alpha diversity will be measured through indices such as Chao, Shannon and Simpson indices. Beta diversity will be measured through standard indices such as Bray-Curtis distances.
Measured: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum ]
Infant: microbiome taxonomic alpha and beta diversity
To define taxonomic diversity, species profiles from 16S, 18S and ITS rDNA data will be clustered to identify differences in community structure across samples. Alpha diversity will be measured through indices such as Chao, Shannon and Simpson indices. Beta diversity will be measured through standard indices such as Bray-Curtis distances.
Measured: 3 and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start24 Nov 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight Gain, PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, University of Toronto, University of Calgary, Dalhousie University, University of Alberta, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar Bhutta, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108675
- Sponsor's protocol ID
- 51950
- Acronym
- MMiP
- Status last verified
- Jul 2023
- First submitted
- 22 Sep 2021
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In addition to publishing findings in open access journals, the investigators will ensure all sequences and metabolomics datasets are deposited in appropriate public repositories of those who consented for this deidentified data sharing. SOPs, pathogen samples and statistical methods developed through this project will be shared with the IMPACTT research core (https://www.impactt-microbiome.ca/). Microbiome sequence data will be uploaded on the National Centre for Biotechnology Information (NCBI). The NCBI acts as a central data repository for sequence data. In line with publication standards, the investigators are required to provide access to users who may wish to follow up on analyzing the microbiome data for their own purposes. The sample analysis information, including the sequencing data and metabolomics data will be de-identified and the patient sequence data will be removed.
Publications
Wasan Y, Baxter JB, Spiegel-Feld C, Begum K, Rizvi A, Iqbal J, Hulst J, Bandsma R, Suleman S, Soofi S, Parkinson J, Bhutta ZA. Elucidating the dynamics and impact of the gut microbiome on maternal nutritional status during pregnancy, effect on pregnancy outcomes and infant health in rural Pakistan: study protocol for a prospective, longitudinal observational study. BMJ Open. 2024 Aug 12;14(8):e081629. doi: 10.1136/bmjopen-2023-081629.
PubMed 39134435
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Dynamics and Impact of the Gut Microbiome on Maternal Nutritional Status During Pregnancy
- ClinicalTrials.gov ID
- NCT05108675
- Acronym / sponsor ID
- MMiP / 51950
- Conditions
- Weight Gain, Pregnancy, Microbial Colonization, Pregnancy Related, Pregnancy Loss, Pregnancy Complications, Pregnancy; Parasitic Disease
- Keywords
- Maternal Malnutrition, Gut Dysbiosis, Infant Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, University of Toronto, University of Calgary, Dalhousie University, University of Alberta, Canadian Institutes of Health Research (CIHR)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nutritional status during pregnancy plays an important role in maternal health and birth outcomes. While few factors impacting nutritional status during pregnancy have been identified, studies of undernutrition in children have revealed a key role for the gut microbiome. Remarkably, studies examining the dynamics of the maternal gut microbiome before and during pregnancy and its impact on birth outcomes are limited.
This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on married pregnant women 24 years and younger living in Matiari District in Pakistan. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. Investigators hypothesizes that alterations of the microbiota in the maternal gut (dysbiosis) is exacerbated by nutritional status or pathogen exposure during pregnancy. This impacts weight gain because of impaired nutrient absorption, and can lead to corresponding negative birth outcomes.
Detailed description
This project represents the first systematic investigation of the impact of the microbiome on nutritional status during pregnancy in young women and directly aligns with global health initiatives focused on this vulnerable cohort. The goal of the study is to define the relationships between host nutritional status and microbiome dynamics during pregnancy and how they contribute to birth outcomes. The gut microbiome has a profound influence on host nutritional status. Dysbiosis (loss of diversity/beneficial microbes and gain of pathobionts) has emerged as a major factor in the development of undernutrition. Despite the importance of nutrition during pregnancy, few studies have examined the role of the microbiome on maternal health and birth outcomes. Further, little is known concerning the influence of enteric eukaryotic microbes, such as parasites, on the bacterial microbiome and host nutrition.
At the core of this study are two complementary cohorts of young women that provide an exceptional opportunity to obtain longitudinal samples to monitor the dynamic relationships between microbiome community structure and function with gut health and host nutritional status. This registration is for the Matiari, Pakistan cohort of the study, where there is known to be a high prevalence of undernutrition among young women. This cohort is expected to yield insights into the influence of eukaryotic microbes that are often viewed as asymptomatic. The target demographic of the study is young, married mothers, ≤24 years in Matiari District within the province of Sindh, Pakistan. Matiari District is representative of rural settings in Pakistan The investigators have identified this younger demographic due to the lack of knowledge on the microbiome of young women, and their vulnerability to undernutrition. A second complementary cohort will be based Toronto, Canada. This project will yield insights into the relationships between prokaryotic and eukaryotic microbes in the gut and their associations with maternal health and birth outcomes.
The central hypothesis of the study is that alterations of the microbiota in the maternal gut (dysbiosis) exacerbated by nutritional status or pathogen exposure during pregnancy, impacts weight gain because of impaired nutrient absorption, leading to corresponding negative birth outcomes.
The study will be a prospective, longitudinal, observational study to investigate the impact and relationship between prokaryotic and eukaryotic microbes in the gut and their association with maternal health and birth outcomes among married young women ≤24 years residing in Matiari District. . The study will aim to recruit 400 women into two groups based on BMI at time of recruitment (normal BMI will be defined as between 20 and 24.9 kg/m2 and low BMI will be defined as less than 20 kg/m2). With a goal of having 200 participants within the normal BMI group and 200 participants within the low BMI group. Although this is the recruitment aim, in the event that the investigators are unable to recruit 200 women with a low BMI, more women will be recruited that fall within the normal BMI range. The study will follow women and their infants over the course of their pregnancy and for a year postpartum, collecting stool, rectal and blood samples, nutritional information, heath assessments, anthropometric measurements and empowerment metrics at different time points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will examine young, married women ≤24 years living in Matiari District, Pakistan. The investigators focus on younger women, due to the lack of knowledge about their microbiome and their vulnerability to undernutrition
Key inclusion criteria (5 listed)
- Consent provided
- Married female aged 17-24 years
- In good general health, with no comorbidities
- Absence of COVID19 symptoms
- Intend to comply with study procedures and follow up
Key exclusion criteria (10 listed)
- Women who do not meet the enrollment age criteria
- Women participating in interventional clinical trials
- Women who intend to leave the study area
- Women who cannot comply with study procedure's and follow-up
- Illness and other co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess if alterations of the microbiota in the maternal gut (dysbiosis) are corelated with changes in maternal gestational weight gain
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception
The primary endpoint will be the change in maternal gestational weight gain (GWG) during pregnancy, measured between the first (8-16 weeks post-conception) and second time point (30-34 weeks post-conception)
To determine the correlation between maternal microbiome dysbiosis during pregnancy and birth weight.
Time frame: At birth
The primary endpoint will be change in birthweight measured in kilograms.
To determine the correlation between maternal microbiome dysbiosis during pregnancy and infant growth
Time frame: 3month, 6month and 12month postpartum
The primary endpoint will be change in WHO z-scores during first year of infant's life. These z-scores will be calculated for weight (measured in kg), length and head circumference (measured in cm).
56 secondary outcomes
Anthropometrics
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, delivery, 3-months post-partum, 6 months post-partum and 12 months post-partum ]
Anthropometrics: Maternal middle upper arm circumference
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum,and 12 months post-partum
Anthropometrics: Maternal triceps skinfold thickness
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, and 12 months post-partum
Anthropometrics: Maternal height
Time frame: 8-16 weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post partum
Anthropometrics: Maternal weight
Time frame: 8-16weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post-partum
Maternal blood biomarker-1
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-2
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-3
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-4
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Infant blood biomarker-1
Time frame: 1 year infant age
Infant blood biomarker-2
Time frame: 1 year infant age
Infant blood biomarker-3
Time frame: 1 year infant age
Infant blood biomarker-4
Time frame: 1 year infant age
Infant sex
Time frame: At birth
Infant morbidity
Time frame: at 3 months, 6 months and 12 months
Maternal morbidity
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, 3 months post-partum, 6 months post-partum and 12 months post-partum
Infant growth: weight
Time frame: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: length
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: head circumference
Time frame: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: mid upper arm circumference
Time frame: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: triceps skinfold thickness
Time frame: within 72 hours of birth, 3 months, 6 months and 12 months
Gestational age at birth
Time frame: Within 72 hours of birth
Maternal age
Time frame: 8-16 weeks post conception
Breast feeding
Time frame: at birth within 72 hours, 3 months, 6 months and 12 months
Reported Maternal medicinal use
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, 6 months post-partum and 12 months post-partum
Reported Infant medication use
Time frame: at birth within 72 hours, 3 months, 6 months and 12 months
Maternal dietary intake Assessed through ASA 24 HR Dietary Recall system, completed 2x each time point
Time frame: Baseline 8-16 weeks post conception, 30-34 weeks post conception and 12 months post partum
Dietary diversity
Time frame: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post-partum and 12 months post partum
Household annual food insecurity
Time frame: 3 months post-partum and 12 months post-partum
Generalized Self-efficacy
Time frame: 3 months post-partum and 12 months post partum
Perceived decision making
Time frame: 3 months post-partum and 12 months post partum
Perceived social support
Time frame: 3 months post-partum and 12 months post partum
Maternal demographics
Time frame: Baseline 8-16 weeks post-conception
Food insecurity
Time frame: Baseline 8-16 weeks post conception, 3 months post partum and 12 months post partum
Perceived parental stress
Time frame: 3 months post-partum and 12 months post partum
Preterm Births
Time frame: At birth within 72 hours
Small for gestational age
Time frame: At birth within 72 hours
Large for gestational age
Time frame: At birth within 72 hours
Delivery Assessment
Time frame: at birth within 72 hours of birth
Infant dietary intake
Time frame: Infant age 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 39134435Wasan Y, Baxter JB, Spiegel-Feld C, Begum K, Rizvi A, Iqbal J, Hulst J, Bandsma R, Suleman S, Soofi S, Parkinson J, Bhutta ZA. Elucidating the dynamics and impact of the gut microbiome on maternal nutritional status during pregnancy, effect on pregnancy outcomes and infant health in rural Pakistan: study protocol for a prospective, longitudinal observational study. BMJ Open. 2024 Aug 12;14(8):e081629. doi: 10.1136/bmjopen-2023-081629.
- Individual participant dataSharing planned: Yes. In addition to publishing findings in open access journals, the investigators will ensure all sequences and metabolomics datasets are deposited in appropriate public repositories of those who consented for this deidentified data sharing. SOPs, pathogen samples and statistical methods developed through this project will be shared with the IMPACTT research core (https://www.impactt-microbiome.ca/). Microbiome sequence data will be uploaded on the National Centre for Biotechnology Information (NCBI). The NCBI acts as a central data repository for sequence data. In line with publication standards, the investigators are required to provide access to users who may wish to follow up on analyzing the microbiome data for their own purposes. The sample analysis information, including the sequencing data and metabolomics data will be de-identified and the patient sequence data will be removed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar Bhutta principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain, Pregnancy and Microbial Colonization, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if alterations of the microbiota in the maternal gut (dysbiosis) are corelated with changes in maternal gestational weight gain (time frame: 8-20 weeks post-conception, 30-34 weeks post-conception). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.