Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT01155804
Status:
UNKNOWN
Last Update Posted:
2011-07-01
First Post:
2010-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2010-06-23', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'To evaluate a well being in women who were receive intense care during prenatal care by the proportion of women with back pain and those with stress urinary incontinence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preparation of the delivery', 'lumbago', 'anxiety', 'urinary incontinence'], 'conditions': ['Lumbago', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '32378735', 'type': 'DERIVED', '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.'}, {'pmid': '26017787', 'type': 'DERIVED', '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.'}, {'pmid': '24007540', 'type': 'DERIVED', '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.'}, {'pmid': '23895188', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant women aged between 16 and 40 years old\n2. gestational age \\>20 weeks\n3. nulliparous women\n4. single fetus\n5. Performing pre-natal care.\n\nExclusion Criteria:\n\n1. Pathological heart condition\n2. diabetes\n3. hypertension\n4. asthma bronchial\n5. HIV+\n6. gestational hypertension\n7. gestational diabetes\n8. pre-eclampsia\n9. persistent bleeding\n10. premature labor\n11. cervical incompetence\n12. acute infection with fever\n13. restriction in fetal growth\n14. indication of elective caesarian-section\n15. in psychotherapy\n16. performing other physical activity more than once a week.'}, 'identificationModule': {'nctId': 'NCT01155804', 'briefTitle': 'Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Center for Research on Reproductive Health of Campinas'}, 'officialTitle': 'Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery', 'orgStudyIdInfo': {'id': 'FAPESP2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercice', 'interventionNames': ['Behavioral: preparation of the delivery']}, {'type': 'OTHER', 'label': 'non-exercice', 'interventionNames': ['Behavioral: preparation of the delivery']}], 'interventions': [{'name': 'preparation of the delivery', 'type': 'BEHAVIORAL', 'description': 'Pregnant nulliparous women allocated to the non-interventional group will follow the routine pre-natal care. The participants of the study group will receive routine attention at the pre-natal care service and will also participate in the program of physical and educational after each routine pre-natal consultation. These activities will be organize as follow: 30 minutes of physical exercise for the prevention of pain and discomfort that may occur during pregnancy, preparation of the perineal muscles for delivery and prevention of urinary incontinence, 15 minutes for relaxation and 30 minutes for group discussion to respond to doubts that women may have and issues such as: change in posture during pregnancy and prevention of pain and discomfort; role of the perineal muscles during pregnancy, delivery and puerperium, physiology of delivery, non-pharmacological way for pain relief and breathing control during contractions of labor and delivery.', 'armGroupLabels': ['Exercice', 'non-exercice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13084-971', 'city': 'Campinas', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Maria Y Makuch, Ph.D.', 'role': 'CONTACT', 'email': 'mmakuch@cemicamp.org.br', 'phone': '551932892856', 'phoneExt': '220'}, {'name': 'Adriana Barros', 'role': 'CONTACT', 'email': 'abarros@cemicamp.org.br', 'phone': '551932892856', 'phoneExt': '209'}, {'name': 'Maria A Miquelutti, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centro de Atençao Integral a Saude da Mulher CAISM', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Research on Reproductive Health of Campinas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Maria Y. Makuch, Ph.D.', 'oldOrganization': 'Cemicamp'}}}}