NCT07081321

Brief Summary

This study is a cohort clinical study. Baseline data were collected from cases recruited at pregnancy, and the eligible subjects were grouped into 3 groups according to different delivery position including supine position group, upright position group, and lateral position group. Different delivery positions along with respectively timeand obstetric conditions were recorded at delivery. Pelvic floor function assessments were performed at postpartum.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
669

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

June 26, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

December 7, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

June 26, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

Stress Urinary inconticenceDlivery positionPelvic Floor muscle strength

Outcome Measures

Primary Outcomes (1)

  • Stress urinary incontence (SUI) occurrence at 6 weeks postpartum

    at 6 (±1) weeks postpartum

Study Arms (3)

Lithotomy Position Group

Participants in the lithotomy position group were in the lithotomy position at the second stage of labor of delivery

Behavioral: Lithotomy position

Upright Position Group

Participants in the upright position group were in the upright position at the second stage of labor of delivery.

Behavioral: Upright Position

Lateral Position.

Participants in the lateral position group were in the lateral position at the second stage of labor of delivery.

Behavioral: Lateral Position

Interventions

Participants in the lithotomy decubitus position group were in the lithotomy position at the second stage of labor of delivery.

Lithotomy Position Group

Participants in the lateral position group were in the lateral position at the second stage of labor of delivery.

Lateral Position.

Participants in the upright position group were in the upright position at the second stage of labor of delivery.

Upright Position Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Singleton, cephalic position, full-term primipara aged 20-35 years old without cephalopelvic disproportion, expected fetal weight ≥ 4000gpelvic floor organ prolapse beyond the hymen limbus and combined with uncontrolled medical diseases and asthma, allergic rhinitis and constipation before pregnancy.

You may qualify if:

  • Age 20-35 years old
  • Singleton, cephalic position, full-term primipara;
  • Cephalopelvic disproportion;
  • Expected fetal weight\< 4000g;
  • Intended vaginal delivery in our hospital;
  • Voluntary participation of study subjects.

You may not qualify if:

  • Pelvic floor organ prolapse beyond the hymen limbus;
  • Combined with uncontrolled medical diseases and asthma, allergic rhinitis and constipation before pregnancy;
  • Presence of contraindications to vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 23, 2025

Study Start

December 7, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations