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The Effect of Different Delivery Positions on Pelvic Floor Function.

P

Peking University

Status

Not yet enrolling

Conditions

Stress Urinary Incontinence (SUI)

Treatments

Behavioral: Lithotomy position
Behavioral: Upright Position
Behavioral: Lateral Position

Study type

Interventional

Funder types

Other

Identifiers

NCT07081321
2025PHB262-004

Details and patient eligibility

About

This study is a prospective, multicenter, randomized controlled trial. Baseline data will be collected from eligible subjects recruited during the third trimester of pregnancy. Participants will be randomized into three groups when cervical dilation reaches 2 cm based on delivery position: lithotomy position, upright position, and lateral position. During the second stage of labor, data regarding delivery positions, duration of each position, and other obstetric conditions will be recorded. Pelvic floor function assessments will be performed in the postpartum period to evaluate the outcomes.

Enrollment

1,992 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Aged 20 to 40 years.
  2. Singleton, cephalic presentation, full-term primipara.
  3. Absence of cephalopelvic disproportion.
  4. Estimated fetal weight (EFW) < 4000 g.
  5. Intended vaginal delivery and scheduled for postpartum follow-up at our hospital.
  6. Voluntary participation with provision of informed consent.

Exclusion criteria

  1. Moderate or severe stress urinary incontinence prior to pregnancy.
  2. Pelvic Organ Prolapse Quantification (POP-Q) stage ≥ III, or a history of treatment for pelvic floor dysfunction.
  3. Uncontrolled systemic medical diseases, or a history of asthma, allergic rhinitis, and constipation prior to pregnancy.
  4. Presence of contraindications to vaginal delivery.
  5. Presence of contraindications to the Valsalva maneuver (e.g., severe cardiopulmonary diseases, cervical incompetence, etc.).

Withdrawal Criteria:

  1. The patient's clinical condition becomes unsuitable for continued study participation and follow-up.
  2. The subject requests to withdraw from the study.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,992 participants in 3 patient groups

Lithotomy Position Group
Experimental group
Description:
Participants in the lithotomy position group were in the lithotomy position at the second stage of labor of delivery
Treatment:
Behavioral: Lithotomy position
Upright Position Group
Experimental group
Description:
Participants in the upright position group were in the upright position at the second stage of labor of delivery.
Treatment:
Behavioral: Upright Position
Lateral Position.
Experimental group
Description:
Participants in the lateral position group were in the lateral position at the second stage of labor of delivery.
Treatment:
Behavioral: Lateral Position

Trial contacts and locations

1

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Central trial contact

Lei Gao, MD

Data sourced from clinicaltrials.gov

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