PregnancyNCT03916354
Maternal Gestational Weight Gain and Microbiota of Maternal and Infant
An observational study of Pregnancy and Gestational Weight Gain, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Gestational Weight Gain, Microbiota
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2019to 31 Dec 2021
- How long will I take part?
- 2 Years
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: About 550 pregnant women meeting the conditions will be recruited from April 2019 to December 2019 during their routine antenatal caer at the first visit.
Who may be able to join
- Ensure a regular prenatal check in the clinical centers.
- 20-45 years old.
- 8-13 gestational weeks.
- Singleton.
- Fully understand and voluntarily sign the informed consent.
Who cannot join
- IUI or IVF-ET pregnancy.
- Smoking or drinking.
- Antibiotics exposure within a month.
- With metabolic syndrome, hypertension, diabetes or dyslipidemia before pregnancy.
- With digestive disease, uncontrolled thyroid disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Medical Univercity College Hospital
Beijing, Beijing Municipality, 100730
Liangkun Ma, 13021961166 ext. 13021961166, MaLiangKun@pumch.cn
About this study
Official title: Clinical Study of the Effect of Gestational Weight Gain on Composition of Gut Microbiome
A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants.
Read the detailed description
Purpose To evaluate whether mothers' gestational weight gain is associated with differences in maternal and their infants gut microbiota characteristics.
Methods and analysis This is a prospective, multicenter, observational cohort study including about 550 mother-infant pairs from PUMCH and other 3 hospitals in Beijing. After signing consent form, every participant will bring home a weighting scale for checking and record the weight every week from they enrolled to a year postpartum. The blood samples, fecal samples, vaginal swabs and oral swabs of the mothers will be collected at first, second, third trimester and postpartum 42 days. The infants' fecal samples will be collected at 0~3, 14, 42 days and 3, 6, 9, 12 months after born. Questionnaire for mothers (diet, exercise, antibiotic and probiotic usage, oral hygiene habits etc.) and their infants (delivery mode, feeding pattern, antibiotic and probiotic usage etc.), as well as the medical records will be collected along with the sample collecting. Bio-specimen will be tested by 16S rRNA gene sequencing. Logistical regression and covariance analysis will be used to determine the relationships between the demographic data, gestational weight gain and microbiota composition.
- Conditions
- Pregnancy, Gestational Weight Gain, Microbiota
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| appropriate GWG group | 2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is in the recommended normal range is in this group. | |
| excess GWG group | 2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is over the upper limit of the recommended normal range is in this group. | |
| insufficient GWG group | 2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is below the lower limit of the recommended normal range is in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal gut microbiota, vaginal microbiota, oral microbiota
The outcome will be measured at first, second and third trimester, as well as 42 days postpartum.
Measured: From enrollment to 42 days postpartum
gut microbiota infants
The outcome will be measured at seven specific time points after the babies delivered.
Measured: From delivery to 1 year postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start7 May 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangkun Ma, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916354
- Sponsor's protocol ID
- HS-1875
- Status last verified
- May 2020
- First submitted
- 12 Apr 2019
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data put together will only be shared by PUMCH and the company, but the article signature will be decided according contribution of the sub-centers.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Effect of Gestational Weight Gain on Composition of Gut Microbiome
- ClinicalTrials.gov ID
- NCT03916354
- Acronym / sponsor ID
- HS-1875
- Conditions
- Pregnancy, Gestational Weight Gain, Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Apr 2019 (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.
A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants.
Detailed description
Purpose To evaluate whether mothers' gestational weight gain is associated with differences in maternal and their infants gut microbiota characteristics.
Methods and analysis This is a prospective, multicenter, observational cohort study including about 550 mother-infant pairs from PUMCH and other 3 hospitals in Beijing. After signing consent form, every participant will bring home a weighting scale for checking and record the weight every week from they enrolled to a year postpartum. The blood samples, fecal samples, vaginal swabs and oral swabs of the mothers will be collected at first, second, third trimester and postpartum 42 days. The infants' fecal samples will be collected at 0~3, 14, 42 days and 3, 6, 9, 12 months after born. Questionnaire for mothers (diet, exercise, antibiotic and probiotic usage, oral hygiene habits etc.) and their infants (delivery mode, feeding pattern, antibiotic and probiotic usage etc.), as well as the medical records will be collected along with the sample collecting. Bio-specimen will be tested by 16S rRNA gene sequencing. Logistical regression and covariance analysis will be used to determine the relationships between the demographic data, gestational weight gain and microbiota composition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| appropriate GWG group | – | –2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is in the recommended normal range is in this group. |
| excess GWG group | – | –2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is over the upper limit of the recommended normal range is in this group. |
| insufficient GWG group | – | –2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is below the lower limit of the recommended normal range is in this group. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- About 550 pregnant women meeting the conditions will be recruited from April 2019 to December 2019 during their routine antenatal caer at the first visit.
Key inclusion criteria (5 listed)
- Ensure a regular prenatal check in the clinical centers.
- 20-45 years old.
- 8-13 gestational weeks.
- Singleton.
- Fully understand and voluntarily sign the informed consent.
Key exclusion criteria (5 listed)
- IUI or IVF-ET pregnancy.
- Smoking or drinking.
- Antibiotics exposure within a month.
- With metabolic syndrome, hypertension, diabetes or dyslipidemia before pregnancy.
- With digestive disease, uncontrolled thyroid disease.
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
maternal gut microbiota, vaginal microbiota, oral microbiota
Time frame: From enrollment to 42 days postpartum
The outcome will be measured at first, second and third trimester, as well as 42 days postpartum.
gut microbiota infants
Time frame: From delivery to 1 year postpartum.
The outcome will be measured at seven specific time points after the babies delivered.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Yes. All data put together will only be shared by PUMCH and the company, but the article signature will be decided according contribution of the sub-centers.
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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.
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 Pregnancy and Gestational Weight Gain, run by Peking Union Medical College Hospital at 1 site in China.
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 5 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 21 May 2020. 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 China. 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?
Contact Liangkun Ma, doctor (13021961166, MaLiangKun@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal gut microbiota, vaginal microbiota, oral microbiota (time frame: From enrollment to 42 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2020.