Manual Rotation in Persistent Occiput Posterior Position

Manual Rotation of A Liveborn Clinical Trial

Official title:

Relation of Ultrasound Parameters Associated to Labor Progression and Manual Rotation's Success in Persistent Occiput Posterior Position

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03271957
• Other study ID #: ManualRotationULisbon
• Status: Not yet recruiting
• Phase: N/A
• First received: July 17, 2017
• Last updated: August 31, 2017
• Start date: October 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2017
• Source: University of Lisbon
• Contact: Catarina R de Carvalho
• Phone: +351919297913
• Email: catarinareiscarvalho[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 1, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Manual Rotation of A Liveborn

Intervention

Procedure:
• Manual rotation
Rotation of the fetal head to an anterior position at time of fuel dilation that is part of routine care

Locations

Country	Name	City	State
Portugal	Departamento de Obstetrícia, Ginecologia e Medicina da Reprodução, Centro hospitalar lisboa norte	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Ana Catarina Reis de Carvalho	University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of manual rotation of the fetal occiput in OP in 2nd stage of labour	After the attempt of manual rotation we will confirm if the fetal occiput, initially in Occiput-posterior (OP) position, is now in Occiput-anterior position (successful rotation) or if is still in OP position (unsuccessful rotation). This confirmation will be made through ultrasound observation.	This outcome will be measure immediately after the attempt of manual rotation
Secondary	Impact of ultrasound measures (progression angle (PA) and dorsal fetal position)	The relation of PA and dorsal fetal position accessed by ultrasound and the success of manual rotation;	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)