RecruitingACTRN12613000005752

The TURN-OUT Trial: Transverse position. Using Rotation to aid Normal birth: OUTcomes following manual rotation.

Among women who are at least 37 weeks gestation, whose baby is in the occiput transverse position early in the second stage of labour, does manual rotation compared with a "sham" rotation, reduce the incidence of operative delivery? (Operative delivery is defined as forceps, ventouse or caesarean section).


Sponsor

Royal Prince Alfred Hospital

Enrollment

416 participants

Start Date

May 2, 2012

Study Type

Interventional

Conditions

Summary

In most labours, the baby is delivered head first, face downwards. When the baby is facing sideways (Occiput Transverse) or upwards (Occiput Posterior), the labour may be more difficult, and assisted deliveries including suction cup, forceps, and caesarean section are more likely. When the mother is fully dilated, it is possible to perform an internal examination and to physically rotate the baby to the downwards (anterior) position, but it is unknown if this procedure reduces the chances of an assisted delivery. We plan to run a study looking at whether performing a procedure to turn the baby will reduce the risk of assisted delivery and caesarean section.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study (called the TURN-OUT Trial) is testing whether manually rotating a baby during labor — when the baby is facing sideways (occiput transverse) or upward instead of face-down — can reduce the need for assisted delivery. Assisted deliveries (with forceps, vacuum, or caesarean) carry risks for both mother and baby. Researchers want to know if gently turning the baby once the mother is fully dilated makes a normal birth more likely. You may be eligible if: - You are female and 18 to 50 years old - You are at least 37 weeks pregnant with a single baby - You are planning a vaginal delivery - Your baby's position is confirmed by ultrasound to be in the occiput posterior position - Your cervix is fully dilated You may NOT be eligible if: - There is a concern that the baby is too large to fit through your pelvis - You have had a previous caesarean section - Your baby's heart rate monitoring is abnormal - There are signs of infection in the uterus (chorioamnionitis) - You have had bleeding greater than 50 mL during labor - You have pre-existing diabetes Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Manual rotation is a procedure that is most commonly performed at full dilatation if the fetal position is occiput posterior (OP) or occiput transverse (OT). It entails the use of the accoucheur's ha

Manual rotation is a procedure that is most commonly performed at full dilatation if the fetal position is occiput posterior (OP) or occiput transverse (OT). It entails the use of the accoucheur's hand or fingers to rotate the fetal head from the OP and OT position to the usual OA position. The procedure takes 4-5 contractions to perform (about 6-10 mins).


Locations(6)

Royal Prince Alfred Hospital - Camperdown

NSW,SA, Australia

Womens and Childrens Hospital - North Adelaide

NSW,SA, Australia

Canterbury Hospital - Campsie

NSW,SA, Australia

Nepean Private Hospital - Kingswood

NSW,SA, Australia

John Hunter Hospital Royal Newcastle Centre - New Lambton

NSW,SA, Australia

Royal Hospital for Women - Randwick

NSW,SA, Australia

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ACTRN12613000005752