Modified Intrapartum Sims Position-related Efficiency in Correction of Persistent Foetal OP Positions

Not Applicable

• Conditions: Persistent Occiput Posterior Position During Labor

• Registration Number: NCT02209090
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia.

Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain.

Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio.

The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.

Detailed Description

Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia.

Background: There is a theoretical basis for the possible effects of maternal positions on foetal positions. Despite all the studies published in recent years, conclusive trials providing significant scientific evidence are lacking.

Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain.

Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio.

The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.

Discussion: If the modified maternal Sims position proved to correct persistent foetal occipito-posterior positions and being a non-invasive, low-cost, non-prejudicial method for both mother and foetus, maternal and foetal morbidity problem would be reduced

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-07-02
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-01
• Last Update Submitted: 2014-08-01
• Study First Posted: 2014-08-05
• Last Update Posted: 2014-08-05
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• adult pregnant women (>18 years of age)
• persistent posterior foetal position diagnosed during labour through two vaginal examinations two hours apart.
• at-term gestations (37 to 42 weeks)
• women in labour with epidural anaesthesia

Exclusion Criteria

• multiple gestations
• previous severe foetal malformation diagnosed
• macrosomic foetus diagnosed by ultrasound in the 3rd trimester (> percentile 95), or IUGR (< percentile 10)
• women with contraindicated vaginal delivery owing to previous vaginal surgeries
• women with severe heart diseases
• diabetic pregnant women (types I, II and gestational)
• hypertension problems during labour
• myopathies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rotation	During labour	the foetal head's capacity to rotate 145º clockwise until the minor fontanelle is situated under the pubic bone, expressed as yes or no, depending on whether there is rotation or not.

Secondary Outcome Measures

Name	Time	Method
rotating to OA	During labour	length of time taken by the foetal head to reach OA expressed in minutes from the start of the intervention
Delivery mode	The first two hours after delivery	eutocic: vaginal delivery, foetal head expulsion in vertex position, spontaneous

Trial Locations

Locations (1)

Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH),; 🇪🇸 Barcelona, Spain