Trial of Ultrasound-guided Rotation for Normalizing Head Position

Intrapartum Ultrasound-Guided Early Manual Rotation for Correcting Abnormal Fetal Head Position: A Randomized Controlled Trial

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.

Inclusion Criteria:

1. Singleton pregnancy, cephalic presentation and term gestation (37⁺⁰ to 41⁺⁶ gestational weeks)

2. Active phase onset at approximately 6 cm cervical dilatation (range defined as 5-7 cm)

3. Either intact or ruptured fetal membranes, with feasibility for intrapartum ultrasonographic assessment

4. Intrapartum ultrasound confirms persistent or definite abnormal fetal occiput position: occiput posterior (OP) or occiput transverse (OT)

5. Manual rotation of fetal head may be considered when cervical dilatation reaches about 6 cm and intrapartum ultrasound demonstrates fetal presenting part below the level of maternal ischial spines (with standardized clinical operator position and corresponding ultrasonic indicators)

6. No contraindications to vaginal delivery; g) Informed consent obtained and signed by the parturient.

   Exclusion Criteria:

7. Non-cephalic presentation, brow presentation or face presentation

8. Suspected significant cephalopelvic disproportion

9. Conditions requiring urgent termination of pregnancy including placenta previa, placental abruption, umbilical cord prolapse and fetal distress

10. Previous scarred uterus unsuitable for trial of vaginal delivery;e) Multiple gestation;f) Major fetal structural anomalies or confirmed fetal chromosomal abnormalities

11. Intrauterine infection, maternal fever or other conditions deemed inappropriate for enrollment by researchers

12. Maternal voluntary refusal of manual fetal head rotation due to fear of labor pain or poor cooperation