Premature Rupture of MembraneNCT03251898
Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
An observational study of Premature Rupture of Membrane and Neonatal Infection, run by Bayi Children's Hospital Affiliated to PLA Army General Hospital, China at 6 sites in China.
Trial summary
This study hypothesizes that early-onset neonatal Infections are related to premature rupture of membrane (PROM) and that early intervention can improve the prognosis of newborns. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Rupture of Membrane, Neonatal Infection
- How many people
- 15,926 participants
- Where
- 6 sitesChina
- Study dates
- 15 Aug 2017to 30 Apr 2018
- How long will I take part?
- 3 Weeks
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The pregnant women who are hospitalized to delivery in the collaborator hospitals.
Who may be able to join
- PROM or chorioamnionitis
- gestational age is ≥ 24 weeks
Who cannot join
- gestational age <24 weeks
- artificial rupture of membrane for labor induction
- natural rupture of membrane during induction before labor
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Chengdu Women's and Children's Central Hospital
Chengdu
Second Hospital of Jilin University
Jilin City
Nanjing Maternity and Child Health Care Hospital
Nanjing
Shenzhen Bao'an Maternal and Child Health Hospital
Shenzhen
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen
Northwest Women's and Children's Hospital
Xi'an
About this study
Official title: Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
This study hypothesizes that early-onset neonatal Infections are related to premature rupture of membrane (PROM) and that early intervention can improve the prognosis of newborns. The objective of this study is to analyze the correlation between PROM and early-onset neonatal infections and to assess the prognosis of newborns. A cohort study is designed to implement the study. The subjects of study group are pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are pregnant women without PROM and chorioamnionitis. Control group and research group are paired at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal infections. (3) The pathogenesis of intrauterine infection and neonatal infection.
- Conditions
- Premature Rupture of Membrane, Neonatal Infection
- Medical subject headings
- Fetal Membranes, Premature Rupture
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 |
|---|---|---|
| study group | pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks | |
| control group | pregnant women without PROM and chorioamnionitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of early-onset neonatal infections
The incidence of early-onset neonatal infections will be compared between study group and control group.
Measured: 7 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start15 Aug 2017
- Primary completion31 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of MembraneStudies 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
- 15,926 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Chengdu Women's and Children's Central Hospital, Shenzhen Maternity & Child Healthcare Hospital, Nanjing Maternity and Child Health Care Hospital, Shenzhen Bao'an Maternal and Child Health Hospital, Second Hospital of Jilin University
- Responsible party
- Sponsor
- Investigators
- Xing Li, Principal investigator, Bayi Children's Hospital Affiliated to PLA Army General Hospital, ChinaShaodong Hua, Principal investigator, Bayi Children's Hospital Affiliated to PLA Army General Hospital, ChinaJie Cui, Principal investigator, Bayi Children's Hospital Affiliated to PLA Army General Hospital, ChinaLei Li, Principal investigator, Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251898
- Sponsor's protocol ID
- BayiChildrens-01
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 27 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
- ClinicalTrials.gov ID
- NCT03251898
- Acronym / sponsor ID
- BayiChildrens-01
- Conditions
- Premature Rupture of Membrane, Neonatal Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,926 participants (actual)
- Lead sponsor
- Bayi Children's Hospital Affiliated to PLA Army General Hospital, ChinaUniversity, hospital or other
- Collaborators
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Chengdu Women's and Children's Central Hospital, Shenzhen Maternity & Child Healthcare Hospital, Nanjing Maternity and Child Health Care Hospital, Shenzhen Bao'an Maternal and Child Health Hospital, Second Hospital of Jilin University
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 16 Aug 2017 (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.
This study hypothesizes that early-onset neonatal Infections are related to premature rupture of membrane (PROM) and that early intervention can improve the prognosis of newborns. The objective of this study is to analyze the correlation between PROM and early-onset neonatal infections and to assess the prognosis of newborns. A cohort study is designed to implement the study. The subjects of study group are pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are pregnant women without PROM and chorioamnionitis. Control group and research group are paired at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal infections. (3) The pathogenesis of intrauterine infection and neonatal infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks |
| control group | – | –pregnant women without PROM and chorioamnionitis |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The pregnant women who are hospitalized to delivery in the collaborator hospitals.
Key inclusion criteria (2 listed)
- PROM or chorioamnionitis
- gestational age is ≥ 24 weeks
Key exclusion criteria (3 listed)
- gestational age <24 weeks
- artificial rupture of membrane for labor induction
- natural rupture of membrane during induction before labor
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
the incidence of early-onset neonatal infections
Time frame: 7 days after birth
The incidence of early-onset neonatal infections will be compared between study group and control group.
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 27 Apr 2020.
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Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
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Preterm Parturation Study
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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.
Xing Li principal investigator
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Shaodong Hua principal investigator
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Jie Cui principal investigator
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Rupture of Membrane and Neonatal Infection, run by Bayi Children's Hospital Affiliated to PLA Army General Hospital, China at 6 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
the incidence of early-onset neonatal infections (time frame: 7 days after birth). 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 27 Apr 2020.