RecruitingACTRN12609000833268

Persistent Occipito-Posterior: Outcomes following digital rotation. The “POPOUT” Pilot Study

In singleton pregnancies of at least 37 weeks gestational age with an occipito-posterior position early in the second stage of labour, does manual rotation reduce the incidence of operative operative delivery rate (forceps/ vontouse/ caesarean section).

Sponsor

Royal Prince Alfred Women and Babies

Enrollment

30 participants

Start Date

Dec 3, 2010

Study Type

Interventional

Conditions

Occipito-posterior position in the second stage of labour

Summary

In most labours, the baby is delivered head first, face downwards. When the baby is facing upwards, 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

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

When a baby is in the womb facing upward (instead of the more common face-down position) during labour, it can make delivery harder and increase the chances of needing help — like forceps, a vacuum cup, or a caesarean section. This study is exploring whether a doctor manually turning the baby to a face-down position once the mother is fully dilated can reduce the need for assisted delivery. It is a small pilot study to see whether a larger trial is practical. You may be eligible if: - You are at least 37 weeks pregnant - You are planning a vaginal delivery - Your baby is head-down but facing upward (occipito-posterior position), confirmed by ultrasound - You are fully dilated (ready to push) - You are between 18 and 45 years old You may NOT be eligible if: - There is concern the baby's head is too large for the birth canal - You have had a previous caesarean section - Your baby is in a brow or face presentation - There are concerning signs on the fetal heart rate monitor - There are signs of infection, heavy bleeding, or fetal distress - Your baby has a known abnormality 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

With an empty bladder, a vaginal examination is performed. If intact, the obstetric membranes are ruptured. The patient is asked to bear down. For the left occipito-posterior (OP) position, the rig

With an empty bladder, a vaginal examination is performed. If intact, the obstetric membranes are ruptured. The patient is asked to bear down. For the left occipito-posterior (OP) position, the right index finger is applied to the right lambdoid suture, exerting constant pressure with the aim of rotating the fetus in an anti-clockwise direction. For the right OP position, the left index finger is used and the fetus rotated in a clockwise direction (28). On the basis of our clinical experience we would aim to rotate the fetus into the occipito-anterior (OA) position over 2 to 3 contractions, then hold the presenting part in this position over another 2 contractions while the woman bears down, to reduce the chances of reversion back to the OP position. The overall expected duration of study is 3 years.

Locations(1)

Australia

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ACTRN12609000833268