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

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Persistent Occiput Posterior Position During Labor

Treatments: Procedure: maternal modified sims position; Procedure: maternal free positions

Study type: Interventional

Funder types: Other

Identifiers

NCT02209090

PR(AMI)182/2012

Details and patient eligibility

About

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.

Full 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

Enrollment: 56 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

maternal modified sims position

Experimental group

Description:

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.

Treatment:

Procedure: maternal modified sims position

maternal free positions

Sham Comparator group

Description:

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.

Treatment:

Procedure: maternal free positions