Gestational HypertensionNCT06907576
Labor Characteristics and Outcomes in Women With Gestational Hypertension or Preeclampsia Who Underwent Labor Induction
An observational study of Gestational Hypertension and Mild Pre-eclampsia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Comparison of Labor Characteristics and Maternal-Neonatal Outcomes in Induced Labor Between Women with Gestational Hypertension/Mild Preeclampsia and Normotensive Controls Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Hypertension, Mild Pre-eclampsia
- How many people
- 425 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Aug 2022
- 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
- Healthy volunteers accepted
- Adult
Study population: This cohort study enrolled 425 pregnant women who underwent IOL, and they were divided into two groups: the HDP group and the normotensive pregnancies group.
Who may be able to join
- Undergoing an induction of labor at term (37-42 weeks) who gave birth to a live born, non-anomalous singleton in cephalic presentation, as well as women aged 18-35 years old
Who cannot join
- Women with pregnancy complications including diabetes mellitus, intrahe-patic cholestasis of pregnancy, placenta previa, placental abruption, oligohydramnios, and polyhydramnios, previous caesarean births, fetal birth weight of ≥4.0 kg, severe preeclampsia, chronic hypertension, prepregnancy hypothyroidism and hyperthyroidism, renal system disease, nutritional deficiency, immune system disease, hematological system diseases, and prepregnancy thrombocytopenia. Women were also excluded if clinical data were incomplete.
Trial locations and contacts
1 site in 1 country.
China1 site
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
About this study
Official title: Comparison of Labor Characteristics and Maternal-Neonatal Outcomes in Induced Labor Between Women With Gestational Hypertension/Mild Preeclampsia and Normotensive Controls
Comparison of Labor Characteristics and Maternal-Neonatal Outcomes in Induced Labor Between Women with Gestational Hypertension/Mild Preeclampsia and Normotensive Controls
Read the detailed description
The American College of Obstetricians and Gynecologists (ACOG) recommends that women with gestational hypertension or preeclampsia without severe features at or beyond 37 weeks of gestation are usually managed by scheduled induction of labor (IOL). Occasionally, normal pregnant women request elective induction of labor because of a perceived decrease in fetal movements in the presence of normal findings in fetal heart rate monitoring. However, there is limited information available to compare labor induction outcomes between patients with gestational hypertension or mild-preeclampsia and those with normal pregnancies. In addition, no studies have analyzed the characteristics and interventions of labor in hypertensive patients with induction of labor who undergone vaginal birth. Therefore, the purpose of this project was to investigate the differences of labor characteristics and maternal-neonatal outcomes with induction of labour (IOL) between pregnant women with gestational hypertension or mild pre-eclampsia and those with normotensive pregnancies, providing clinical references of intrapartum management for women with gestational hypertension or mild pre-eclampsia.
Our results showed that women with hypertensive pregnancies had higher rates of cesarean delivery due to failed induction compared to normotensive pregnancies. However, no significant differences were observed in induced labor characteristics, intrapartum interventions, and maternal-neonatal complications between women with gestational hypertension or mild pre-eclampsia and those with normotensive pregnancies. Parity, bishop score, birth weight, and the hypertensive disorders of pregnancy were independently and significantly associated with an increased risk of cesarean section following induction. Consequently, these findings could provide evidence for the intrapartum management of labor induction in women with gestational hypertension or mild pre-eclampsia.
- Conditions
- Gestational Hypertension, Mild Pre-eclampsia
- Keywords
- induction of labor, gestational hypertension, mild pre-eclampsia
- Medical subject headings
- Hypertension, Pregnancy-Induced
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 |
|---|---|---|
| the HDP group | The pregnant women had combined with gestational hypertension or mild pre-eclampsia. | |
| the normotensive pregnancies group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of cesarean delivery
pregnant outcome
Measured: 35 weeks to 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Aug 2017
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Hua, Study director, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907576
- Sponsor's protocol ID
- SAHoWMU-CR2025-07-209
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Labor Characteristics and Maternal-Neonatal Outcomes in Induced Labor Between Women With Gestational Hypertension/Mild Preeclampsia and Normotensive Controls
- ClinicalTrials.gov ID
- NCT06907576
- Acronym / sponsor ID
- SAHoWMU-CR2025-07-209
- Conditions
- Gestational Hypertension, Mild Pre-eclampsia
- Keywords
- induction of labor, gestational hypertension, mild pre-eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 2 Apr 2025 (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.
Comparison of Labor Characteristics and Maternal-Neonatal Outcomes in Induced Labor Between Women with Gestational Hypertension/Mild Preeclampsia and Normotensive Controls
Detailed description
The American College of Obstetricians and Gynecologists (ACOG) recommends that women with gestational hypertension or preeclampsia without severe features at or beyond 37 weeks of gestation are usually managed by scheduled induction of labor (IOL). Occasionally, normal pregnant women request elective induction of labor because of a perceived decrease in fetal movements in the presence of normal findings in fetal heart rate monitoring. However, there is limited information available to compare labor induction outcomes between patients with gestational hypertension or mild-preeclampsia and those with normal pregnancies. In addition, no studies have analyzed the characteristics and interventions of labor in hypertensive patients with induction of labor who undergone vaginal birth. Therefore, the purpose of this project was to investigate the differences of labor characteristics and maternal-neonatal outcomes with induction of labour (IOL) between pregnant women with gestational hypertension or mild pre-eclampsia and those with normotensive pregnancies, providing clinical references of intrapartum management for women with gestational hypertension or mild pre-eclampsia.
Our results showed that women with hypertensive pregnancies had higher rates of cesarean delivery due to failed induction compared to normotensive pregnancies. However, no significant differences were observed in induced labor characteristics, intrapartum interventions, and maternal-neonatal complications between women with gestational hypertension or mild pre-eclampsia and those with normotensive pregnancies. Parity, bishop score, birth weight, and the hypertensive disorders of pregnancy were independently and significantly associated with an increased risk of cesarean section following induction. Consequently, these findings could provide evidence for the intrapartum management of labor induction in women with gestational hypertension or mild pre-eclampsia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the HDP group | – | –The pregnant women had combined with gestational hypertension or mild pre-eclampsia. |
| the normotensive pregnancies group | – | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This cohort study enrolled 425 pregnant women who underwent IOL, and they were divided into two groups: the HDP group and the normotensive pregnancies group.
Key inclusion criteria (1 listed)
- Undergoing an induction of labor at term (37-42 weeks) who gave birth to a live born, non-anomalous singleton in cephalic presentation, as well as women aged 18-35 years old
Key exclusion criteria (1 listed)
- Women with pregnancy complications including diabetes mellitus, intrahe-patic cholestasis of pregnancy, placenta previa, placental abruption, oligohydramnios, and polyhydramnios, previous caesarean births, fetal birth weight of ≥4.0 kg, severe preeclampsia, chronic hypertension, prepregnancy hypothyroidism and hyperthyroidism, renal system disease, nutritional deficiency, immune system disease, hematological system diseases, and prepregnancy thrombocytopenia. Women were also excluded if clinical data were incomplete.
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 rate of cesarean delivery
Time frame: 35 weeks to 40 weeks gestation
pregnant outcome
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 2 Apr 2025.
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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.
Ying Hua study director
Second Affiliated Hospital of Wenzhou Medical 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 Gestational Hypertension and Mild Pre-eclampsia, run by Second Affiliated Hospital of Wenzhou Medical 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 1 inclusion and 1 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 2 Apr 2025. 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?
the rate of cesarean delivery (time frame: 35 weeks to 40 weeks gestation). 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 2 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.