Epidural analgesia side effect Pregnancy and Childbirth Epidural analgesia side effect
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women who are between 14 and 20 weeks pregnant 2. Aged from 18 to 40 years-old 3. Pregnancy at low risk of complications (i.e. all women have singleton pregnancies, and none have medical, obstetric, or psychiatric problems)
Exclusion criteria
Exclusion criteria: 1. Severe and poorly controlled hypertension, type 1 diabetes, or asthma 2. Hemodynamically significant heart disease, recent episode of deep venous thrombosis, hepatic insufficiency, or renal failure 3. Diagnosed mental illness or contraindications for physical activity 4. Multiparity (=6 pregnancies), recurrent spontaneous miscarriages (=3), incompetent cervix, increased risk of premature labor, persistent second or third trimester bleeding, uncontrolled gestational diabetes, severe isoimmunization, or planned Caesarean section 5. Severe anemia (hemoglobin 20 cigarettes/day), any drug use or abuse, chronic infectious disease (HIV, hepatitis B, hepatitis C) 6. Not being able to swim 7. Communication difficulties 8. Unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of epidural analgesia use during labour is determined through review of the clinical history at one month after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Morbidity (major complications, poor labor progress, intrapartum maternal fever) is determined through review of the clinical history at one month after birth 2. Pregnancy weight gain is is determined through review of the clinical history at one month after birth 3. Induction of labour is determined through review of the clinical history at one month after birth 4. Method of delivery is determined through review of the clinical history at one month after birth 5. Episiotomy or perineal tear is determined through review of the clinical history at one month after birth 6. Total labor pain is measured using a visual analogue scale (VAS) at one month after birth 7. Postnatal depression is measured using the Edinburgh postnatal depression scale (EPDS) at one month after birth 8. Health resource utilisation is determined through review of the clinical history at one month after birth 9. Quality of life is measured using the EuroQol Five Dimension questionnaire (EQ-5D) at one month after birth 10. Neonatal medical outcomes (intrapartum fetal distress, birth weight, gestational age, Apgar score, pH umbilical cord blood) is determined through review of the clinical history at one month after birth 11. Quality and quantity of sleep is measured using the Medical Outcomes Study (MOS) sleep scale at gestation times of 17, 27, and 37 weeks 12. Physical activity is measured using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at gestation times of 17, 27, and 37 weeks 13. Perceived exertion during physical activity is measured using the Modified Borg scale (MBS) at gestation times of 17, 27, and 37 weeks | — |
Countries
Spain