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

Randomised Clinical Trial: Modified Intrapartum Maternal Sims Position-related Efficiency in the Correction of Persistent Foetal Occipito-posterior Position

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.

Study Overview

• Status: Unknown
• Conditions: Persistent Occiput Posterior Position During Labor
• Intervention / Treatment: Procedure: maternal modified sims position; Procedure: maternal free positions

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 Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Bueno, Midwife; Email: vanessabuenolopez@gmail.com

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH),
    • Contact: Vanessa Bueno, Midwife; Phone Number: 0034934893086; Email: vanessabuenolopez@gmail.com
    • Principal Investigator: Vanessa Bueno, Midwife
    • Sub-Investigator: Terré Carmen, PhD
    • Sub-Investigator: Casellas Manel, PhD
    • Sub-Investigator: Teva Asunción, midwife

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: maternal modified sims position; Women in this group will adopt the modified Sims position, lying on the side of the foetal back. This position is maintained for the greater part of labour, at least 40 minutes, every hour. The mother can use other positions during resting time of no more than 20 minutes each hour, but never use a lateral position against the side of the foetal back.	Procedure: maternal modified sims position; Maternal Modified Sims position during at least 40 minutes for each 60 minutes
Sham Comparator: maternal free positions; Women can adopt the position they wish and which is most comfortable, except for lateral positions which can only be used for a maximum of 20 minutes each hour to avoid confounding factors.	Procedure: maternal free positions; At least 40 minutes each hour during labour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotation	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.	During labour

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
uterine dynamics	assessed by frequency and intensity according to Monteviedo unit calculation	During labour
first stage in minutes	timed in minutes, from 3cm with cervix shortened until complete diltation.	During labour
second stage in minutes	timed from complete dilation to foetal head expulsion	The first two hours after delivery
epidural anaesthesia	doses of epidural anaesthesia required, concentration and ml.	During labour
episiotomy	whether performed or not to gain a major opening from the soft parts of the birth canal.	The first two hours after delivery
tear	trauma occurring spontaneously by the foetal head passing through the vaginal cavity and/or perineum:	The first two hours after delivery
reason to end labour earlier	cause that occurs on ending labour before it concludes spontaneously. Reasons may be foetal: risk of loss of foetal wellbeing, or maternal: pelvic foetal disproportion or stopped labour	The first two hours after delivery
maternal comfort during labour	MACKEY SATISFACTION CHILDBIRTH RATING SCALE validated in Spanish	The first two hours after delivery

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: University of Barcelona
• Investigators: Principal Investigator: Vanessa Bueno, PhDcandidate, HUValldebronRI

Publications and helpful links

General Publications

• Bueno-Lopez V, Fuentelsaz-Gallego C, Casellas-Caro M, Falgueras-Serrano AM, Crespo-Berros S, Silvano-Cocinero AM, Alcaine-Guisado C, Zamoro Fuentes M, Carreras E, Terre-Rull C. Efficiency of the modified Sims maternal position in the rotation of persistent occiput posterior position during labor: A randomized clinical trial. Birth. 2018 Dec;45(4):385-392. doi: 10.1111/birt.12347. Epub 2018 Mar 14.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 1, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: labour; occiput-posterior; occipitoposterior
• Other Study ID Numbers: PR(AMI)182/2012