Effects of Antenatal Exercises on Clinical Outcomes in Pregnant Females With Gestational Diabetes Mellitus

NCT04859348 | Completed DMC

• 1 other identifier: IRB-UOL-FAHS/600-1/2020
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Gestational diabetes mellitus (GDM) GDM is the most common complication that affects the health of the child and mother during pregnancy. Objectives was to determine the effects of Antenatal exercises on glucose levels, mode of delivery and APGAR Score in females with gestational diabetes mellitus. This Randomized controlled trial study was conducted on N= 72 pregnant females at department of Gynecology and Obstetrics, Mian Munshi DHQ Hospital, Lahore after Ethical approval of synopsis from institutional Review Board of the University of Lahore . The data was entered and analyzed using SPSS Version 24. .

Conditions

Gestational Diabetes

Keywords

Antenatal Exercise; APGAR Score; C-section; Mode of delivery; Pregnancy

Outcome Measures

Primary Outcomes (3)

• Glucose level

  Effect of antenatal exercise on glucose level was measured by test beta HbAc1 performed by gynecology department before delivery

  4 months

• mode of delivery

  effect of antenatal exercise on type of delivery was studied as it was normal vaginal or caesarian section

  4 months

• APGAR Score

  effect of antenatal exercise on APGAR score was studied which describe fetal health after delivery

  4 months

Study Arms (2)

Group-A ( RPT+ Insulin Therapy)

EXPERIMENTAL

Group A includes participants received the routine physical therapy only.

Other: routine physical therapy

Group-B (RPT+ Antenatal Exercises+ Insulin therapy)

EXPERIMENTAL

Group B includes participants were given antenatal exercise program from 20- 24 weeks of gestation to till the date of delivery, with addition of the routine physical therapy plan.

Other: routine physical therapy and antenatal exercises

Interventions

routine physical therapy OTHER

G- A 36 participants received only routine treatment for GDM which includes insulin therapy and diet control guided by gynecologist and routine physical therapy which includes walk for 1 hr with proper warm up and cool down periods, three times in a week from 20-24 weeks of gestation to till delivery.

Group-A ( RPT+ Insulin Therapy)

routine physical therapy and antenatal exercises OTHER

G- B 36 participants receive routine therapy (insulin therapy and diet control) and Aerobic and strengthening Exercises for 3 days a week, for 2 weeks 6 sessions under the supervision of physiotherapist and remaining was performed at home. Exercise was started from 15 min and reach to 30 mins gradually.10-15-minute warm-up, cool-down period was included by using ACOG Guideline. Aerobic exercise includes a brisk walk and strengthening exercise were performed with hold for 5 seconds and 10 repetitions. Exercise should stop if they experience any signs of dizziness, dyspnea, amniotic fluid leaking or vaginal bleeding. Confidentiality and blindness ensure by random allocation.

Group-B (RPT+ Antenatal Exercises+ Insulin therapy)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Panel patients who are covered under medical facility provided by the company
• Booked cases
• Participant's Borg scale score 6 to 14
• Age 20-35 years
• weeks of gestation
• Diagnosed case of GDM
• Primigravida
• BMI does not exceed 40 kg/m²

You may not qualify if:

• Females diagnosed with vascular complications (Preeclampsia, hemolysis etc.)
• Uncontrolled diabetes mellitus
• Autonomic dysfunction /Peripheral neuropathy (Damage to the nerves outside of the brain and spinal cord which effect sensations)
• Nephropathy or retinopathy (Damage to the small blood vessels of kidneys and eyes)
• Twins fetus
• Placenta Previa (placenta partially or totally covers the mother's cervix)
• Fetal anomalies
• Female choice for caesarean section
• Intrauterine growth retardation (fetal complication)
• Short cervix length
• Antepartum hemorrhage (bleeding from the genital tract)

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Anumsattar8@Gmail.Com

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anum Sattar, MPhil

  student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes accessor donot know the type of intervention given to patient not during evaluation or data record
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: G- A 36 participants received only routine treatment for GDM G- B 36 participants receive routine therapy (insulin therapy and diet control) and Aerobic and strengthening Exercises.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: November 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 16, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: December 2021 data will available approximately
• Access Criteria: Any one can access the data

Locations

PA (1)