Clinical trial NCT01155804: Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Official title: Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lumbago
Anxiety
Keywords: preparation of the delivery
lumbago
anxiety
urinary incontinence
Lead sponsor: Center for Research on Reproductive Health of Campinas
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-07-02
Enrollment: 192
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Objective: to evaluate the effectively of the Program for Preparation of Pregnant Women for Delivery on the prevention of physical and psychological difficulties and problems during pregnancy and delivery in nulliparous women participating in the program. Subjects and methods: a randomized clinical single blind trial will be conducted with 192 pregnant nulliparous women allocated to participate or not of the program activities. The women allocated to the study group will participate of physical and educational activities at each pre-natal consultation and will receive orientation on the exercises they will perform at their home. Participants of the non-interventional group will follow the habitual routine care at the service. Participants will be selected among nulliparous low risk pregnant women aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be performing by intention to treat. For the continues variables the t-Student or Wilcoxon test will be performing; for the categorical variables the tests x² or Fisher, and the risk estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures between the groups and along time, and correlation tests for anxiety and physical activity with gestational and perinatal variables.

Detailed description: Participants, 192 nulliparous women that receive pre-natal care, allocated according to randomization into two groups: group one in which the women who participate in a program with physical and educational activities and the non-interventional group that will not receive the intervention and will follow a regular pre-natal care at routine of the service. The designation of participants will be performed, after informed consent will be sign, by opening sequentially envelopes previously sealed and numbered that will contain the information, previously generated by a computer system.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women aged between 16 and 40 years old
2. gestational age \>20 weeks
3. nulliparous women
4. single fetus
5. Performing pre-natal care.

Exclusion Criteria:

1. Pathological heart condition
2. diabetes
3. hypertension
4. asthma bronchial
5. HIV+
6. gestational hypertension
7. gestational diabetes
8. pre-eclampsia
9. persistent bleeding
10. premature labor
11. cervical incompetence
12. acute infection with fever
13. restriction in fetal growth
14. indication of elective caesarian-section
15. in psychotherapy
16. performing other physical activity more than once a week.

Primary outcomes:
measure: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence
timeFrame: The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Centro de Atençao Integral a Saude da Mulher CAISM
state: SP
Study officials:
References:
citation: Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
citation: Miquelutti MA, Cecatti JG, Makuch MY. Developing strategies to be added to the protocol for antenatal care: an exercise and birth preparation program. Clinics (Sao Paulo). 2015 Apr;70(4):231-6. doi: 10.6061/clinics/2015(04)02.
citation: Miquelutti MA, Cecatti JG, Makuch MY. Antenatal education and the birthing experience of Brazilian women: a qualitative study. BMC Pregnancy Childbirth. 2013 Sep 5;13:171. doi: 10.1186/1471-2393-13-171.
citation: Miquelutti MA, Cecatti JG, Makuch MY. Evaluation of a birth preparation program on lumbopelvic pain, urinary incontinence, anxiety and exercise: a randomized controlled trial. BMC Pregnancy Childbirth. 2013 Jul 29;13:154. doi: 10.1186/1471-2393-13-154.