Aerobic water exercise during pregnancy for reducing use of epidural analgesia

• Register: ISRCTN
• Last refreshed on: 23 October 2023
• Main ID: ISRCTN14097513
• Date of registration: 04/09/2017
• Prospective Registration: No
• Primary sponsor: Primary Care Management Mallorca (Gerencia de Atención primaria de Mallorca)
• Public title: Aerobic water exercise during pregnancy for reducing use of epidural analgesia
• Scientific title: Effectiveness and safety of moderate-intensity aerobic water exercise during pregnancy for reducing use of epidural analgesia during labor
• Date of first enrolment: 09/10/2014
• Target sample size: 320
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14097513
• Study type: Interventional
• Study design: Multi-center parallel randomised evaluator-blinded controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Alfonso leiva Rus

Key inclusion & exclusion 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:
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 < 9 mg/dL), recurrent urinary tract or vaginal infection, BMI above 35 or below 17, active and heavy smoker (>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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Epidural analgesia side effect
Pregnancy and Childbirth
Epidural analgesia side effect

Intervention(s)

After entry details are recorded on a trial entry form, participants are randomised to either the the aquatic-aerobic exercise group or the usual antenatal care group. The 1:1 randomization is performed by a researcher not involved with treatment allocation, and are in balanced blocks of six.

Group 1: The women randomized to the water aerobics group participate in 45 min water aerobics classes held three times weekly in an indoor pool (28-30°C) for five months. This procedure is based on recommendations of the American College of Sports Medicine (36), which proposes 3-5 classes per week, a training zone of 55-65% of maximum heart rate, classes of 20-60 min duration, maximum heart rate of 140 bpm, and maintenance of body temperature below 38°C.

Aquatic exercise includes four sets of exercise were developed for the study, each set of exercise include exercises that looks at the full work of muscle groups and include breathing and relaxation techniques. All exercises are performed with coordinating breathing and includes the following:
1. Warm-up out of water (5 to 7 min)
2. Warm-up in water (5 to 10 min)
3. Moderate aquatic exercise (20 min)
4. Breathing and relaxation exercises (5 min)
5. Playful exercises (5 min)
The intervention will stop if any of the followings events appear during the trial: metrorrhagia, placenta previa, premature rupture of membranes, intrauterine growth retardation, severe anemia, or any contraindications to being physically active.

Group 2: Women in the control group receive standard antenatal care, and the customary information given by a midwife or general practitioner. They are not

Primary Outcome(s)

The incidence of epidural analgesia use during labour is determined through review of the clinical history at one month after birth

Secondary Outcome(s)

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

Secondary ID(s)

PI13/02400

Source(s) of Monetary Support

Ministerio de Economía y Competitividad

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Primary Care Research Committee Mallorca Ethical Committee of Clinical Research, 24/07/2014, ref: IB 2358/14 PI

Results

• Results available: Yes
• Date Completed: 19/12/2017