Clinical trial NCT01389128: Non-pharmacological Resources in Assisting Labor
Official title: Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labour Pain
Keywords: labor
pain
massage
natural birth
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed project will be conducted to evaluate the influence of application resources associated with non-pharmacological during labor for pain relief and accelerated phase of expansion. Although mothers' access to resources for non-pharmacological pain relief during labor is recommended, is not seen as the application of routine obstetric practice, although it has been demonstrated benefits and scientific evidence with your application. It is believed that the implementation of associated application of non-pharmacological resources in assisting the labor can be introduced into daily practice in various hospitals in the country, minimizing pain and favoring the shorter duration of labor, decrease in use of painkillers and inductors, resulting in a reduction of complications, improves the comfort of the mother making her birth experience more satisfying and rewarding, being assisted with security and trained by multidisciplinary teams.

Detailed description: The current model of care delivery has demanded a technical-assistance approach that prioritizes the quality of care, as indissolubly concerns the employment of technology, knowledge, the centrality of dialogue between professionals and patients and individualized choice resources deemed suitable for safe delivery. Seeking to implement a less interventionist care with evidence-based practice and greater incentive to vaginal delivery, the programs were created humanization of labor and birth, with the use of various non-pharmacological resources. This study aimed to evaluate the effectiveness of the combination of non-pharmacological resources during the dilation in relieving the pain of the mothers. The research will be of type randomized controlled trial, consisting of low-risk primigravidae admitted at the Reference Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (intervention protocol features non-drug) and Control (routine maternity) and will be evaluated before and after application of each resource, and the control group in the same time according to cervical dilation. Evaluation will be conducted by a visual analog scale and / or facial pain and pain location diagram and postpartum will be applied a validated questionnaire Experience and Satisfaction with childbirth. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p \<0.05 to obtain the statistical significance of 5%.

Eligibility criteria: Inclusion Criteria:- Agreed to participate in the study after reading and signing the consent form;

* Primigravida;
* Pregnancy only;
* Gestational age ≥ 37 weeks;
* Presentation fetal head
* Chorioamniotic intact membranes
* Working with spontaneous onset of labor
* Admission at the beginning of active phase dilation (4-5 cm)
* Lack of maternal and fetal pathologies
* Literacy - primary education
* Absence of cognitive problems

Exclusion Criteria:

* Pregnant women admitted for induction of labor
* Rupture premature or early of chorioamniotic membranes
* Use of uterotonic drugs before the active phase

Primary outcomes:
measure: Pain Relief
timeFrame: ten hours
Secondary outcomes:
measure: Evolution of Labor
timeFrame: 10 hours
measure: Moment That Women Requested Analgesia During the Active Phase of Labor
timeFrame: 10 hours
measure: Number of Women Who Received Pharmacological Analgesia
timeFrame: 10 hours
measure: Type of Delivery
timeFrame: 10 hours
measure: Number of Participants Whose Neonates Had:
timeFrame: 10 hours
measure: Number of Participants With:
timeFrame: 10 hours
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Referral Center Women's Health - Mater
state: São Paulo
Study officials:
affiliation: Faculty of Medicine of São Paulo University
name: Silvana M Quintana, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. doi: 10.1016/j.ajog.2003.12.008.
citation: Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. J Physiother. 2018 Jan;64(1):33-40. doi: 10.1016/j.jphys.2017.11.014. Epub 2017 Dec 27.