Walking and Dietary Modification for Recurrent Early Miscarriages

NCT03023137 | Completed Results

• 1 other identifier: HospitalSERJ
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of a big one aiming to evaluate how lifestyle interventions during pregnancy affect obstetric results, neonatal metabolism and the intelligence of the offspring (study not yet completed). Data regarding obstetric and neonatal results were entered in NCT01409382, but we decided to split results in two for the sake of clarity. A cohort of women with early pregnancy losses without antiphospholipid antibodies was selected for two reasons. One is that these women follow strictly the recommendadtions. The second is that no medication has been shown to increase the rate of take-home babies in women with early miscarriages who test negative for antiphospholipid antibodies. We decided to focus on the fibrinolytic system because trophoblast migration and placental vasculogenesis and angiogenesis depend on plasmin-dependent extracellular matrix remodeling. Plasminogen activator inhibitor (PAI)-1 inhibits the generation of plasmin. Since both glucose and insulin increase PAI-1 synthesis, hyperglycemia itself, or by stimulating insulin production, reduces plasmin generation, which may impair placentation. Abnormalities in glucose metabolism may be also deleterious to embryos by causing epigenetic changes. Chromosomal abnormalities are considered an important cause of early pregnancy losses. Several lines of evidence lend support to the hypothesis that carbohydrate metabolism abnormalities contribute to the pathogenesis of recurrent early pregnancy losses. One is that of the pregnancies of the women with polycystic ovary syndrome, around 30 and 50% end with first-trimester miscarriages. Hyperinsulinemia is a prevalent feature of the syndrome, and interventions proven effective in reducing insulin levels, such as metformin, have been shown to reduce the rate of early miscarriages. The other is that patients with body mass index of ≥25 kg/m2 have significantly higher odds of early miscarriage, regardless of the method of conception. The investigator's hypothesis was that a balanced diet combined to regular exercise, by improving glucose homeostasis, would increase the take-home baby rate in women with consecutive early miscarriages. Moderate exercises are usually well tolerated not only by the mother, but also by the fetus, as indicated by tests of fetal well-being, including umbilical artery systolic to diastolic ratio.

Conditions

Recurrent Miscarriage

Keywords

prevention; carbohydrate; exercise; neonatal hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Take-home Baby Rate

  End of pregnancy

Secondary Outcomes (10)

• Gestational Diabetes Mellitus

  Pregnancies reaching 24 weeks' gestation

• Preeclampsia

  Pregnancies reaching 20 weeks' gestation

• Mothers Who Used Heparin for Nephrotic Range Proteinuria or Placental Insufficiency

  End of pregnancy

• Excessive Weight Gain

  End of term pregnancies

• First-trimester Losses

  14 weeks of gestation

Study Arms (2)

Walking & dietary modification (W&D)

ACTIVE COMPARATOR

W\&D should begin when participants wish to conceive. The intervention was standardized by training of research staff. Careful instructions about walking speed and diet would be given to participants assigned to W\&D at enrolment and at each consultation.

Behavioral: Walking & dietary modification

Controls

NO INTERVENTION

No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.

Interventions

Walking & dietary modification BEHAVIORAL

1. Daily walking at a moderate pace (4 km/h) \> 40 min, 7/7. Those remaining seated most of the day should walk 25-30 min twice a day, avoiding \>12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, which often occurred near term and when the mother was obese. 2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants are recommended to use ondansetron for nausea and vomiting prevention

Also known as: W&D

Walking & dietary modification (W&D)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 2 consecutive pregnancy losses in the first trimester;
• losses should be documented by pathology or ultrasound-confirmed gestational sac.

You may not qualify if:

• anatomic anomalies that may increase the risk of pregnancy losses, not amenable to surgical correction during pregnancy, such as uterine septum;
• antiphospholipid antibodies;
• prior second- or third-trimester losses;
• current multiple gestation;
• disabilities such as hemiplegia or paraplegia;
• renal or liver failure;
• conditions requiring a priori anticoagulation

Sponsors & Collaborators

• Hospital dos Servidores do Estado do Rio de Janeiro: lead

Study Sites (1)

Hospital Federal dos Servidores do Estado, Ministry of Health

Rio de Janeiro, Rio de Janeiro, 20221-903, Brazil

Location

MeSH Terms

Conditions

Abortion, Habitual; Motor Activity

Interventions

Walking; Diet Therapy

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Nutrition Therapy; Therapeutics

Limitations and Caveats

An important limitation of this study is that it did not assess the exact composition of the participants' diet. Another limitation is that the use of heparin use was not controlled in this study.

Results Point of Contact

• Title: Dr. Silvia Hoirisch-Clapauch
• Organization: Hospital Federal dos Servidores do Estado

sclapauch@gmail.com

5521999737500

Study Officials

• Silvia Hoirisch-Clapauch, MD, PhD

  Hospital Federal dos Servidores do Estado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants were not blinded, but visits of the two groups were scheduled so as to not coincide..
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: May 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 10, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)