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| Name | Class |
|---|---|
| University of Barcelona | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maternal modified sims position | Experimental | 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. |
|
| maternal free positions | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maternal modified sims position | Procedure | Maternal Modified Sims position during at least 40 minutes for each 60 minutes |
|
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Bueno, Midwife | Contact | vanessabuenolopez@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vanessa Bueno, PhDcandidate | HUValldebronRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Area Materno Infantil of the Hospital Univeristario Vall d'Hebron (AMI HUVH), | Recruiting | Barcelona | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29537658 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 5, 2017 | |
| Reset | Jun 19, 2017 |
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| maternal free positions | Procedure | At least 40 minutes each hour during labour |
|
| The first two hours after delivery |
| 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 5, 2017 | Jun 19, 2017 |