Clinical trial NCT03271957: Manual Rotation in Persistent Occiput Posterior Position
Official title: Relation of Ultrasound Parameters Associated to Labor Progression and Manual Rotation's Success in Persistent Occiput Posterior Position
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Manual Rotation of A Liveborn
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: University of Lisbon
First posted: 2017-09-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women in the delivery room that fulfill the inclusion criteria

Brief summary: Is part of routine obstetric care to attempt a manual rotation in all fetus that are in a persistent OP at delivery. Nevertheless, little is known about the success of this intervention or about the relation of some ultrasound measures with the outcome.

Detailed description: Persistent OP at delivery occurs in approximately 10% of fetuses and studies have shown an increase in short-term and long-term maternal and fetal complications such as prolonged labour, maternal exhaustion, fetal distress, instrumental delivery, caesarean delivery and severe perineal tears. Manual rotation of the fetal occiput to OA position has been described as a safe and effective intervention in the setting of labour arrest but evidence is limited. Therefore, the investigators aim to evaluate:

1. The success of manual rotation of the fetal occiput in OP in 2nd stage of labour; The relation of progression angle (PA) accessed by ultrasound and the success of manual rotation; This is as prospective study with a sample size calculated of 50 participants.

1. º Identify an OP position during digital examination in the first evaluation at full cervical dilatation (t=0)
2. º Get informed consent from the pregnant woman.
3. º Wait for the first urge to push or T=30 m (multiparous) or T=60 (nulliparous)
4. º Confirm fetal head position by ultrasound and measure PA.
5. º Attempt a manual rotation to anterior position accordingly to the protocol.
6. º Confirm fetal head position by ultrasound.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies
* \>37 weeks of pregnancy
* Fetus in cephalic presentation
* Fetal weight estimation P10-90
* Fetal head in a posterior position in the moment of full cervical dilatation.

Exclusion Criteria:

- do not give or do not be able to give written consent

Primary outcomes:
measure: Success of manual rotation of the fetal occiput in OP in 2nd stage of labour
timeFrame: This outcome will be measure immediately after the attempt of manual rotation
Secondary outcomes:
measure: Impact of ultrasound measures (progression angle (PA) and dorsal fetal position)
timeFrame: The PA and dorsal fetal position will be measure after the diagnose of full dilatation when occurs the first urge to push or 30 minutes after the diagnose of full dilatation (multiparous) or 60 minutes after the diagnose of full dilatation (nulliparous)
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Departamento de Obstetrícia, Ginecologia e Medicina da Reprodução, Centro hospitalar lisboa norte
Study officials:
affiliation: Obstetrics' Director
name: Nuno Clode, MD
role: STUDY_DIRECTOR
References: