Trial of Ultrasound-guided Rotation for Normalizing Head Position

Summary

Intrapartum Ultrasound-Guided Early Manual Rotation for Correcting Abnormal Fetal Head Position The goal of this clinical trial is to learn whether using ultrasound during labor, followed by early manual rotation of the baby's head when needed, can help more women give birth vaginally when the baby's head is facing an unfavorable direction.

During labor, most babies turn so the back of the head faces the front of the mother's pelvis. This position usually makes birth easier. Some babies remain in a back-facing or side-facing position, called occiput posterior or occiput transverse position. These positions may make labor longer and may raise the chance of assisted vaginal birth or cesarean birth.

In this study, trained midwives or obstetric clinicians will use intrapartum ultrasound, which is an ultrasound scan during labor, to check the baby's head position. Ultrasound is non-invasive and can give a clearer and more objective picture than examination by touch alone. If the baby's head is in an unfavorable position and the participant meets the study safety criteria, the clinician may try manual rotation. Manual rotation means using the hand to gently help turn the baby's head into a more favorable front-facing position.

Researchers will compare two groups. One group will receive ultrasound-guided early manual rotation when the cervix is about 5 to 7 centimeters open and the baby's head is low enough. The other group will receive usual labor care, including standard examinations and usual clinical management. Participants will be assigned to one of these groups by chance, like flipping a coin.

The main question is: Does ultrasound-guided early manual rotation increase the chance of vaginal birth? The study will also learn about safety and other birth outcomes, including whether the baby's head turns successfully, how long labor lasts, whether forceps or cesarean birth is needed, bleeding after birth, fever or possible infection, perineal injury, the mother's birth experience, breastfeeding, and newborn outcomes such as Apgar score, umbilical cord blood pH, need for resuscitation, birth injury, or admission to the neonatal intensive care unit.

Participants will:

* Have eligibility checked during labor.
* Have an ultrasound scan to check the baby's head position.
* Be randomly assigned to one of the study groups if they meet the study criteria.
* Continue to receive close labor monitoring, including fetal heart rate monitoring.
* Have birth and newborn information collected from medical records.
* Complete follow-up after birth, including up to 42 days after delivery. Possible benefits include a better chance that the baby's head turns to a favorable position, a higher chance of vaginal birth, and fewer complications related to prolonged or difficult labor. These benefits are not guaranteed.

Possible risks include discomfort or pain during manual rotation, failed rotation, temporary fetal heart rate changes, vaginal or cervical injury, bleeding, or the need for urgent clinical care, including cesarean birth. The study team will stop the procedure and provide standard care if there are safety concerns.

Taking part is voluntary. A participant may choose not to join or may leave the study at any time. This will not affect the usual care provided to the mother or baby.

Conditions

• Abnormal Fetal Head Position

Interventions

PROCEDURE

Trial of Ultrasound-guided Rotation for Normalizing Head position

This project introduces intrapartum ultrasonography combined with the manual cephalic rotation procedure. Midwives use intrapartum ultrasonography for early detection of abnormal fetal occiput positions . When cervical dilation reaches approximately 6 cm and the fetal presenting part is 1-1.5 cm below the ischial spine, manual cephalic rotation is performed to shift the fetal head to the occiput anterior position, allowing delivery through the maternal pelvis along the smallest cranial diameter (suboccipitobregmatic diameter). Observed maternal outcome indicators include the success rate of manual cephalic rotation, vaginal delivery rate, forceps delivery rate, conversion-to-cesarean delivery rate, duration of labor, episiotomy rate, severe perineal laceration rate and incidence of perineal hematoma; neonatal indicators cover the incidence of infants with 1-minute Apgar score ≤7, umbilical artery blood gas parameters and neonatal birth trauma rate.

PROCEDURE

Standard Care plus Sham Ultrasound

Arm Description: All participants receive routine intrapartum management in our hospital. Interventions for the control group are as follows: a) Fetal position and labor progress are assessed via routine vaginal examination. b) Labor surveillance, labor analgesia and oxytocin titration are administered according to clinical indications. c) Sham ultrasound examination A newly purchased intrapartum ultrasound machine is used for sham ultrasound assessment. Only basic assessments including cephalic presentation confirmation and amniotic fluid volume measurement are performed; evaluation of fetal occiput position and other relevant parameters is omitted to avoid contamination between subjects allocated to different groups within the same ward. d) Given the difficulty in accurate fetal position diagnosis during the first stage of labor, manual fetal head rotation is performed once abnormal fetal position is identified by midwives, typica

Sponsors & Collaborators

• The First Affiliated Hospital, University of Science and Technology of China

  collaborator OTHER

• Anhui Provincial Hospital

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-12-31

Completion

2028-03-31