Very Low Birth Weight BabyNCT01335490
Intervening to Improve Infant Health in Ghana
A study testing Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel in people with Very Low Birth Weight Baby and Pneumonia, run by Columbia University at 2 sites in 2 countries.
Trial summary
The purpose of the study is to understand how cooking might affect the health of pregnant women and their babies. The goal of the research is to determine whether, interventions in decreasing exposure to smoke from cook stoves can bring about a significant change in the indoor air pollution levels and health of… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Very Low Birth Weight Baby, Pneumonia
- What is being tested?
- Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,414 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2013to Mar 2016
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
A cluster was eligible to participate if it:
- Is located in Kintampo North or South Districts (this is the core study area for KHRC)
- Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people);
- Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges);
- Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries).
A woman will be eligible to participate in the study if she:
- Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks)
- Is carrying a live singleton fetus (twins will be excluded)
- Is the primary cook in her household or compound; and
- Is a non-smoker.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Intervening to Improve Birth Weight and Infant Respiratory Health in Rural Ghana
The purpose of the study is to understand how cooking might affect the health of pregnant women and their babies.
The goal of the research is to determine whether, interventions in decreasing exposure to smoke from cook stoves can bring about a significant change in the indoor air pollution levels and health of communities in Ghana.
Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead to a significant increase in average birth weight in newborns.
Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of severe acute lower respiratory disease during the first 12 months of life.
Read the detailed description
- Overview of design and analysis [per CONSORT 2010] 2.1 Trial design [CONSORT 3a] The study is a three-arm cluster randomized trial, with two intervention arms and a control arm. The primary justification for intervening at the village level is that an individual level randomization, which would entail treatments and controls living side-by-side in a village, could lead to conflict within villages.
2.2 Study Participants [CONSORT 4a, 4b] The study will take place in the catchment area of Kintampo Health Research Centre. This comprises a population of 146,000. The study population is primarily rural and agricultural, and cooks primarily with biomass fuels. The study area is well described in Owusu-Agyei et al. 2012 (38).
A cluster was eligible to participate if it:
- Is located in Kintampo North or South Districts (this is the core study area for KHRC)
- Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people);
- Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges);
- Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries).
A woman will be eligible to participate in the study if she:
- Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks)
- Is carrying a live singleton fetus (twins will be excluded)
- Is the primary cook in her household or compound; and
- Is a non-smoker. 2.3 Interventions [CONSORT 5]
The study has three arms:
- LPG intervention arm, in which households receive a two burner LPG cookstove and monthly gas deliveries;
- An efficient biomass arm, in which households receive two BioLite cookstoves; and
- A control arm 2.4 Outcomes [CONSORT 6a]
The primary health outcome measures for the study are:
- Infant weight at birth, and
- Physician assessed pneumonia. Baseline assessments of outcomes No baseline data for ALRI prevalence from Ghana is available. Our study will thus provide very valuable baseline data regarding this important disease.
KHRC has, in the course of conducting other research projects, captured some information regarding birth weight; statistics calculated from these data were used as inputs into power calculations. These data are described in (39).
2.5 Sample size [CONSORT 7a, 7b] For the three-arm design, we calculate that we need to enroll households to achieve our target of 1225 births (assuming that 85% of the pregnancies will result in a recorded birth after, accounting for move out, drop out, and still birth rates). These will be spread across 35 or more clusters, as outlined in the following table.
Clusters Births Enrollment BioLite 13 455 525 Control 13 455 525 LPG 9 315 365 total 35 1225 1415
- Conditions
- Very Low Birth Weight Baby, Pneumonia
- Being tested
- Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuelOther
The cooking stoves will reduce air emissions significantly in the home, resulting in improved infant health. It will be given to the mother in the second or third trimester.
| Study group | Role | What they receive |
|---|---|---|
| Biolite Cook Stove | Experimental | Provision of two cook stoves to each subject. Each stove burns wood fuel, but more efficiently than a traditional three stone fire. Receives: Other: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel |
| LPG Cook Stove | Experimental | Provision of a two-burner liquified petroleum gas stove to each subject, along with fuel needed for the family during the follow up period. Receives: Other: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low birth weight
Measured: Birth
Secondary outcomes (1)
Acute lower respiratory disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight BabyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Global Alliance for Clean Cookstoves, Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Patrick Kinney, ScD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335490
- Sponsor's protocol ID
- AAAF3520
- Other IDs
- 1R01ES019547-01A1
- Status last verified
- Jul 2017
- First submitted
- 13 Apr 2011
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Agyapong PD, Jack D, Kaali S, Colicino E, Mujtaba MN, Chillrud SN, Osei M, Gennings C, Agyei O, Kinney PL, Kwarteng A, Perzanowski M, Dwommoh Prah RK, Tawiah T, Asante KP, Lee AG. Household Air Pollution and Child Lung Function: The Ghana Randomized Air Pollution and Health Study. Am J Respir Crit Care Med. 2024 Mar 15;209(6):716-726. doi: 10.1164/rccm.202303-0623OC.
PubMed 38016085Boamah-Kaali E, Jack DW, Ae-Ngibise KA, Quinn A, Kaali S, Dubowski K, Oppong FB, Wylie BJ, Mujtaba MN, Gould CF, Gyaase S, Chillrud S, Owusu-Agyei S, Kinney PL, Asante KP, Lee AG. Prenatal and Postnatal Household Air Pollution Exposure and Infant Growth Trajectories: Evidence from a Rural Ghanaian Pregnancy Cohort. Environ Health Perspect. 2021 Nov;129(11):117009. doi: 10.1289/EHP8109. Epub 2021 Nov 29.
PubMed 34842444Jack DW, Ae-Ngibise KA, Gould CF, Boamah-Kaali E, Lee AG, Mujtaba MN, Chillrud S, Kaali S, Quinn AK, Gyaase S, Oppong FB, Carrion D, Agyei O, Burkhart K, Ana-Aro JA, Liu X, Berko YA, Wylie BJ, Etego SA, Whyatt R, Owusu-Agyei S, Kinney P, Asante KP. A cluster randomised trial of cookstove interventions to improve infant health in Ghana. BMJ Glob Health. 2021 Aug;6(8):e005599. doi: 10.1136/bmjgh-2021-005599.
PubMed 34452940Kinney PL, Asante KP, Lee AG, Ae-Ngibise KA, Burkart K, Boamah-Kaali E, Twumasi M, Gyaase S, Quinn A, Oppong FB, Wylie BJ, Kaali S, Chillrud S, Yawson A, Jack DW, Owusu-Agyei S. Prenatal and Postnatal Household Air Pollution Exposures and Pneumonia Risk: Evidence From the Ghana Randomized Air Pollution and Health Study. Chest. 2021 Nov;160(5):1634-1644. doi: 10.1016/j.chest.2021.06.080. Epub 2021 Jul 21.
PubMed 34298005Ae-Ngibise KA, Wylie BJ, Boamah-Kaali E, Jack DW, Oppong FB, Chillrud SN, Gyaase S, Kaali S, Agyei O, Kinney PL, Mujtaba M, Wright RJ, Asante KP, Lee AG. Prenatal maternal stress and birth outcomes in rural Ghana: sex-specific associations. BMC Pregnancy Childbirth. 2019 Oct 29;19(1):391. doi: 10.1186/s12884-019-2535-9.
PubMed 31664941Lee AG, Kaali S, Quinn A, Delimini R, Burkart K, Opoku-Mensah J, Wylie BJ, Yawson AK, Kinney PL, Ae-Ngibise KA, Chillrud S, Jack D, Asante KP. Prenatal Household Air Pollution Is Associated with Impaired Infant Lung Function with Sex-Specific Effects. Evidence from GRAPHS, a Cluster Randomized Cookstove Intervention Trial. Am J Respir Crit Care Med. 2019 Mar 15;199(6):738-746. doi: 10.1164/rccm.201804-0694OC.
PubMed 30256656Quinn AK, Ae-Ngibise KA, Kinney PL, Kaali S, Wylie BJ, Boamah E, Shimbo D, Agyei O, Chillrud SN, Mujtaba M, Schwartz JE, Abdalla M, Owusu-Agyei S, Jack DW, Asante KP. Ambulatory monitoring demonstrates an acute association between cookstove-related carbon monoxide and blood pressure in a Ghanaian cohort. Environ Health. 2017 Jul 21;16(1):76. doi: 10.1186/s12940-017-0282-9.
PubMed 28732501Jack DW, Asante KP, Wylie BJ, Chillrud SN, Whyatt RM, Ae-Ngibise KA, Quinn AK, Yawson AK, Boamah EA, Agyei O, Mujtaba M, Kaali S, Kinney P, Owusu-Agyei S. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial. Trials. 2015 Sep 22;16:420. doi: 10.1186/s13063-015-0930-8.
PubMed 26395578Boamah EA, Asante K, Ae-Ngibise K, Kinney PL, Jack DW, Manu G, Azindow IT, Owusu-Agyei S, Wylie BJ. Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol Development, and Ongoing Quality Control. JMIR Res Protoc. 2014 Dec 18;3(4):e77. doi: 10.2196/resprot.3797.
PubMed 25525828
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening to Improve Birth Weight and Infant Respiratory Health in Rural Ghana
- ClinicalTrials.gov ID
- NCT01335490
- Acronym / sponsor ID
- AAAF3520
- Conditions
- Very Low Birth Weight Baby, Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,414 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Global Alliance for Clean Cookstoves, Thrasher Research Fund
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Apr 2011 (estimated)
- 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.
The purpose of the study is to understand how cooking might affect the health of pregnant women and their babies.
The goal of the research is to determine whether, interventions in decreasing exposure to smoke from cook stoves can bring about a significant change in the indoor air pollution levels and health of communities in Ghana.
Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead to a significant increase in average birth weight in newborns.
Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of severe acute lower respiratory disease during the first 12 months of life.
Detailed description
- Overview of design and analysis [per CONSORT 2010] 2.1 Trial design [CONSORT 3a] The study is a three-arm cluster randomized trial, with two intervention arms and a control arm. The primary justification for intervening at the village level is that an individual level randomization, which would entail treatments and controls living side-by-side in a village, could lead to conflict within villages.
2.2 Study Participants [CONSORT 4a, 4b] The study will take place in the catchment area of Kintampo Health Research Centre. This comprises a population of 146,000. The study population is primarily rural and agricultural, and cooks primarily with biomass fuels. The study area is well described in Owusu-Agyei et al. 2012 (38).
A cluster was eligible to participate if it:
- Is located in Kintampo North or South Districts (this is the core study area for KHRC)
- Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people);
- Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges);
- Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries).
A woman will be eligible to participate in the study if she:
- Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks)
- Is carrying a live singleton fetus (twins will be excluded)
- Is the primary cook in her household or compound; and
- Is a non-smoker. 2.3 Interventions [CONSORT 5]
The study has three arms:
- LPG intervention arm, in which households receive a two burner LPG cookstove and monthly gas deliveries;
- An efficient biomass arm, in which households receive two BioLite cookstoves; and
- A control arm 2.4 Outcomes [CONSORT 6a]
The primary health outcome measures for the study are:
- Infant weight at birth, and
- Physician assessed pneumonia. Baseline assessments of outcomes No baseline data for ALRI prevalence from Ghana is available. Our study will thus provide very valuable baseline data regarding this important disease.
KHRC has, in the course of conducting other research projects, captured some information regarding birth weight; statistics calculated from these data were used as inputs into power calculations. These data are described in (39).
2.5 Sample size [CONSORT 7a, 7b] For the three-arm design, we calculate that we need to enroll households to achieve our target of 1225 births (assuming that 85% of the pregnancies will result in a recorded birth after, accounting for move out, drop out, and still birth rates). These will be spread across 35 or more clusters, as outlined in the following table.
Clusters Births Enrollment BioLite 13 455 525 Control 13 455 525 LPG 9 315 365 total 35 1225 1415
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biolite Cook Stove | Experimental | Other: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuelProvision of two cook stoves to each subject. Each stove burns wood fuel, but more efficiently than a traditional three stone fire. |
| LPG Cook Stove | Experimental | Other: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuelProvision of a two-burner liquified petroleum gas stove to each subject, along with fuel needed for the family during the follow up period. |
| Control | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuelThe cooking stoves will reduce air emissions significantly in the home, resulting in improved infant health. It will be given to the mother in the second or third trimester. | Other | Biolite Cook Stove, LPG Cook Stove |
Primary outcome
Low birth weight
Time frame: Birth
1 secondary outcome
Acute lower respiratory disease
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Derived from this study: PubMed 38016085Agyapong PD, Jack D, Kaali S, Colicino E, Mujtaba MN, Chillrud SN, Osei M, Gennings C, Agyei O, Kinney PL, Kwarteng A, Perzanowski M, Dwommoh Prah RK, Tawiah T, Asante KP, Lee AG. Household Air Pollution and Child Lung Function: The Ghana Randomized Air Pollution and Health Study. Am J Respir Crit Care Med. 2024 Mar 15;209(6):716-726. doi: 10.1164/rccm.202303-0623OC.
- Derived from this study: PubMed 34842444Boamah-Kaali E, Jack DW, Ae-Ngibise KA, Quinn A, Kaali S, Dubowski K, Oppong FB, Wylie BJ, Mujtaba MN, Gould CF, Gyaase S, Chillrud S, Owusu-Agyei S, Kinney PL, Asante KP, Lee AG. Prenatal and Postnatal Household Air Pollution Exposure and Infant Growth Trajectories: Evidence from a Rural Ghanaian Pregnancy Cohort. Environ Health Perspect. 2021 Nov;129(11):117009. doi: 10.1289/EHP8109. Epub 2021 Nov 29.
- Derived from this study: PubMed 34452940Jack DW, Ae-Ngibise KA, Gould CF, Boamah-Kaali E, Lee AG, Mujtaba MN, Chillrud S, Kaali S, Quinn AK, Gyaase S, Oppong FB, Carrion D, Agyei O, Burkhart K, Ana-Aro JA, Liu X, Berko YA, Wylie BJ, Etego SA, Whyatt R, Owusu-Agyei S, Kinney P, Asante KP. A cluster randomised trial of cookstove interventions to improve infant health in Ghana. BMJ Glob Health. 2021 Aug;6(8):e005599. doi: 10.1136/bmjgh-2021-005599.
- Derived from this study: PubMed 34298005Kinney PL, Asante KP, Lee AG, Ae-Ngibise KA, Burkart K, Boamah-Kaali E, Twumasi M, Gyaase S, Quinn A, Oppong FB, Wylie BJ, Kaali S, Chillrud S, Yawson A, Jack DW, Owusu-Agyei S. Prenatal and Postnatal Household Air Pollution Exposures and Pneumonia Risk: Evidence From the Ghana Randomized Air Pollution and Health Study. Chest. 2021 Nov;160(5):1634-1644. doi: 10.1016/j.chest.2021.06.080. Epub 2021 Jul 21.
- Derived from this study: PubMed 31664941Ae-Ngibise KA, Wylie BJ, Boamah-Kaali E, Jack DW, Oppong FB, Chillrud SN, Gyaase S, Kaali S, Agyei O, Kinney PL, Mujtaba M, Wright RJ, Asante KP, Lee AG. Prenatal maternal stress and birth outcomes in rural Ghana: sex-specific associations. BMC Pregnancy Childbirth. 2019 Oct 29;19(1):391. doi: 10.1186/s12884-019-2535-9.
- Derived from this study: PubMed 30256656Lee AG, Kaali S, Quinn A, Delimini R, Burkart K, Opoku-Mensah J, Wylie BJ, Yawson AK, Kinney PL, Ae-Ngibise KA, Chillrud S, Jack D, Asante KP. Prenatal Household Air Pollution Is Associated with Impaired Infant Lung Function with Sex-Specific Effects. Evidence from GRAPHS, a Cluster Randomized Cookstove Intervention Trial. Am J Respir Crit Care Med. 2019 Mar 15;199(6):738-746. doi: 10.1164/rccm.201804-0694OC.
- Derived from this study: PubMed 28732501Quinn AK, Ae-Ngibise KA, Kinney PL, Kaali S, Wylie BJ, Boamah E, Shimbo D, Agyei O, Chillrud SN, Mujtaba M, Schwartz JE, Abdalla M, Owusu-Agyei S, Jack DW, Asante KP. Ambulatory monitoring demonstrates an acute association between cookstove-related carbon monoxide and blood pressure in a Ghanaian cohort. Environ Health. 2017 Jul 21;16(1):76. doi: 10.1186/s12940-017-0282-9.
- Derived from this study: PubMed 26395578Jack DW, Asante KP, Wylie BJ, Chillrud SN, Whyatt RM, Ae-Ngibise KA, Quinn AK, Yawson AK, Boamah EA, Agyei O, Mujtaba M, Kaali S, Kinney P, Owusu-Agyei S. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial. Trials. 2015 Sep 22;16:420. doi: 10.1186/s13063-015-0930-8.
- Derived from this study: PubMed 25525828Boamah EA, Asante K, Ae-Ngibise K, Kinney PL, Jack DW, Manu G, Azindow IT, Owusu-Agyei S, Wylie BJ. Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol Development, and Ongoing Quality Control. JMIR Res Protoc. 2014 Dec 18;3(4):e77. doi: 10.2196/resprot.3797.
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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.
Patrick Kinney, ScD principal investigator
Columbia University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel in people with Very Low Birth Weight Baby and Pneumonia, run by Columbia University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ghana. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Low birth weight (time frame: Birth). 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 NCT01335490, which also lists 9 linked publications.
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 18 Jul 2017.