The Effect of Different Delivery Positions on Pelvic Floor Function.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 20 to 40 years.

Singleton, cephalic presentation, full-term primipara.

Absence of cephalopelvic disproportion.

Estimated fetal weight (EFW) < 4000 g.

Disqualifiers

Moderate or severe stress urinary incontinence prior to pregnancy.

Pelvic Organ Prolapse Quantification (POP-Q) stage ≥ III, or a history of treatment for pelvic floor dysfunction.

Uncontrolled systemic medical diseases, or a history of asthma, allergic rhinitis, and constipation prior to pregnancy.

Presence of contraindications to vaginal delivery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lithotomy position

    Behavioral

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

  • Lateral Position

    Behavioral

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

  • Upright Position

    Behavioral

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

Treatment groups

1,992 Participants
are divided into 3 treatment groups
Group A: Lithotomy Position GroupExperimental treatment 1 intervention
Group B: Upright Position GroupExperimental treatment 1 intervention
Group C: Lateral Position.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stress urinary incontence (SUI) occurrence at 6 weeks postpartum

Time frame
at 6 (±2) weeks postpartum

Secondary outcomes

Other outcomes

Sponsors and contacts

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Peking University People's Hospital

Lead sponsor

Luohe Central Hospital

Collaborator

The Third Xiangya Hospital of Central South University

Collaborator

Zhengzhou Central Hospital

Collaborator

Jincheng People's Hospital

Collaborator

Tongzhou Maternal and Child Healthcare Hospital of Beijing

Collaborator

Hangzhou maternity and child health care hospital

Collaborator

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