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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Persistent Occiput Posterior Position During Labor

Intervention / Treatment
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* Procedure: maternal modified sims position
* Procedure: maternal free positions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: maternal modified sims position<br>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<br>* Maternal Modified Sims position during at least 40 minutes for each 60 minutes<br>|
| Sham Comparator: maternal free positions<br>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<br>* At least 40 minutes each hour during labour<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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occiput-posterior, occipitoposterior, labour