Labor OnsetNCT07839364
Maternal Oral Microbiota and Immune Signatures Associated With Spontaneous Labor Onset
An observational study of Labor Onset, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study investigates how the oral microbiome (the community of microorganisms living in the mouth) and immune system change around the time of spontaneous labor onset in healthy pregnant women. We will enroll 55 healthy pregnant women at full term (37 weeks or later). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Labor Onset
- What is being tested?
- None (Observational Study)
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2025to 22 Jan 2026
- How long will I take part?
- 2 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 18 to 35 years
- Women only
- Adult
Study population: Healthy pregnant women at full term (37-40 gestational weeks) recruited from the Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China. Participants are aged 18-35 years with a pre-pregnancy BMI of 18.5-23.9 kg/m², naturally conceived singleton pregnancies, and no obstetric complications. Participants are grouped according to the presence or absence of spontaneous labor onset: labor-onset group (LO, n=28) and non-labor group (NLO, n=27).
Who may be able to join
- Pregnant women aged 18 to 35 years
- Pre-pregnancy body mass index (BMI) of 18.5 to 23.9 kg/m²
- Naturally conceived singleton pregnancy
- No obstetric complications
- Written informed consent obtained prior to enrollment
Who cannot join
- Polyhydramnios, oligohydramnios, gestational hypertension, gestational diabetes, or other pregnancy-related disorders
- History of cervical surgery or previous preterm birth
- Antibiotic or probiotic use during the current pregnancy
- Current oral diseases or dental/oral procedures within the previous six months
- Uterine malformations
- Chronic conditions such as immune system disorders, hypertension, diabetes, gastrointestinal diseases, or hyperthyroidism
- Smoking, alcohol consumption, or other adverse lifestyle habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Oral Microbiota and Immune Signatures Associated With Spontaneous Labor Onset: A Prospective Observational Study
This study investigates how the oral microbiome (the community of microorganisms living in the mouth) and immune system change around the time of spontaneous labor onset in healthy pregnant women.
We will enroll 55 healthy pregnant women at full term (37 weeks or later). Participants will be divided into two groups: women who have begun labor and women who have not yet begun labor. We will collect saliva samples to analyze the oral bacteria using genetic sequencing, and collect blood and placental samples to measure immune factors (proteins that help regulate the body's immune response).
By comparing the two groups, we aim to identify specific bacteria and immune factors that are associated with the start of labor. This research will help us better understand the biological processes that trigger childbirth and may contribute to improved prediction and management of labor onset.
- Conditions
- Labor Onset
- Being tested
- None (Observational Study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational Study)Other
This is an observational study with no intervention administered. Participants are grouped based on the presence or absence of spontaneous labor onset.
| Study group | Role | What they receive |
|---|---|---|
| Labor-Onset Group (LO) | Not described Receives: Other: None (Observational Study) | |
| Non-Labor Group (NLO) | Not described Receives: Other: None (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in oral microbiota composition between labor-onset and non-labor groups
Relative abundance of oral microbiota (%), assessed by 16S rRNA gene sequencing of the V3-V4 hypervariable regions (primers 341F/806R), with paired-end 2 x 250 bp sequencing on the Illumina NovaSeq 6000 platform, in saliva samples from 55 participants (LO, n = 28; NLO, n = 27)
Measured: At sample collection (39-40 gestational weeks for NLO group; first stage of labor for LO group)
Differences in plasma immune factor levels between labor-onset and non-labor groups
Concentration of immune markers, including TLR-4, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-18, IL-22, TNF-α, and IL-1β (pg/mL), in plasma, assessed by enzyme-linked immunosorbent assay (ELISA) using commercially available kits (Shanghai Fusheng Industrial Co., Ltd.), in 55 participants (LO, n = 28; NLO, n = 27)
Measured: At sample collection (39-40 gestational weeks for NLO group; first stage of labor for LO group)
Differences in placental immune factor levels between labor-onset and non-labor groups
Concentration of immune markers, including TLR-4, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-18, IL-22, TNF-α, and IL-1β (pg/mL), in placental tissue homogenates, assessed by enzyme-linked immunosorbent assay (ELISA) using commercially available kits (Shanghai Fusheng Industrial Co., Ltd.), in 50 participants (LO, n = 25; NLO, n = 25)
Measured: At sample collection (placental tissues collected within 15 minutes postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start22 Jan 2025
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor OnsetStudies 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
- 55 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhe Li, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839364
- Sponsor's protocol ID
- KY-2025-025
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Oral Microbiota and Immune Signatures Associated With Spontaneous Labor Onset: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07839364
- Acronym / sponsor ID
- KY-2025-025
- Conditions
- Labor Onset
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 24 Sep 2026 (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 investigates how the oral microbiome (the community of microorganisms living in the mouth) and immune system change around the time of spontaneous labor onset in healthy pregnant women.
We will enroll 55 healthy pregnant women at full term (37 weeks or later). Participants will be divided into two groups: women who have begun labor and women who have not yet begun labor. We will collect saliva samples to analyze the oral bacteria using genetic sequencing, and collect blood and placental samples to measure immune factors (proteins that help regulate the body's immune response).
By comparing the two groups, we aim to identify specific bacteria and immune factors that are associated with the start of labor. This research will help us better understand the biological processes that trigger childbirth and may contribute to improved prediction and management of labor onset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labor-Onset Group (LO) | – | Other: None (Observational Study) |
| Non-Labor Group (NLO) | – | Other: None (Observational Study) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Healthy pregnant women at full term (37-40 gestational weeks) recruited from the Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China. Participants are aged 18-35 years with a pre-pregnancy BMI of 18.5-23.9 kg/m², naturally conceived singleton pregnancies, and no obstetric complications. Participants are grouped according to the presence or absence of spontaneous labor onset: labor-onset group (LO, n=28) and non-labor group (NLO, n=27).
Key inclusion criteria (5 listed)
- Pregnant women aged 18 to 35 years
- Pre-pregnancy body mass index (BMI) of 18.5 to 23.9 kg/m²
- Naturally conceived singleton pregnancy
- No obstetric complications
- Written informed consent obtained prior to enrollment
Key exclusion criteria (7 listed)
- Polyhydramnios, oligohydramnios, gestational hypertension, gestational diabetes, or other pregnancy-related disorders
- History of cervical surgery or previous preterm birth
- Antibiotic or probiotic use during the current pregnancy
- Current oral diseases or dental/oral procedures within the previous six months
- Uterine malformations
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 |
|---|---|---|
| None (Observational Study)This is an observational study with no intervention administered. Participants are grouped based on the presence or absence of spontaneous labor onset. | Other | Labor-Onset Group (LO), Non-Labor Group (NLO) |
Primary outcome
Differences in oral microbiota composition between labor-onset and non-labor groups
Time frame: At sample collection (39-40 gestational weeks for NLO group; first stage of labor for LO group)
Relative abundance of oral microbiota (%), assessed by 16S rRNA gene sequencing of the V3-V4 hypervariable regions (primers 341F/806R), with paired-end 2 x 250 bp sequencing on the Illumina NovaSeq 6000 platform, in saliva samples from 55 participants (LO, n = 28; NLO, n = 27)
Differences in plasma immune factor levels between labor-onset and non-labor groups
Time frame: At sample collection (39-40 gestational weeks for NLO group; first stage of labor for LO group)
Concentration of immune markers, including TLR-4, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-18, IL-22, TNF-α, and IL-1β (pg/mL), in plasma, assessed by enzyme-linked immunosorbent assay (ELISA) using commercially available kits (Shanghai Fusheng Industrial Co., Ltd.), in 55 participants (LO, n = 28; NLO, n = 27)
Differences in placental immune factor levels between labor-onset and non-labor groups
Time frame: At sample collection (placental tissues collected within 15 minutes postpartum)
Concentration of immune markers, including TLR-4, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-18, IL-22, TNF-α, and IL-1β (pg/mL), in placental tissue homogenates, assessed by enzyme-linked immunosorbent assay (ELISA) using commercially available kits (Shanghai Fusheng Industrial Co., Ltd.), in 50 participants (LO, n = 25; NLO, n = 25)
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 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Labor Onset, run by Third Affiliated Hospital, Sun Yat-Sen University 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 7 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 24 Sep 2026. 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?
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?
Differences in oral microbiota composition between labor-onset and non-labor groups (time frame: At sample collection (39-40 gestational weeks for NLO group; first stage of labor for LO group)). 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?
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 24 Sep 2026.