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Walking and Dietary Modification for Recurrent Early Miscarriages (W&D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023137
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : April 6, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Silvia Hoirisch Clapauch, Hospital dos Servidores do Estado do Rio de Janeiro

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.


Condition or disease Intervention/treatment Phase
Recurrent Miscarriage Behavioral: Walking & dietary modification Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Participants were not blinded, but visits of the two groups were scheduled so as to not coincide..
Primary Purpose: Prevention
Official Title: Walking and Dietary Modification for Women With Consecutive Early Miscarriages: a Randomized Study
Study Start Date : May 2011
Actual Primary Completion Date : August 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arm Intervention/treatment
Active Comparator: Walking & dietary modification (W&D)
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
  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
Other Name: W&D

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



Primary Outcome Measures :
  1. Take-home Baby Rate [ Time Frame: End of pregnancy ]

Secondary Outcome Measures :
  1. Gestational Diabetes Mellitus [ Time Frame: Pregnancies reaching 24 weeks' gestation ]
  2. Preeclampsia [ Time Frame: Pregnancies reaching 20 weeks' gestation ]
  3. Mothers Who Used Heparin for Nephrotic Range Proteinuria or Placental Insufficiency [ Time Frame: End of pregnancy ]
  4. Excessive Weight Gain [ Time Frame: End of term pregnancies ]
    Weight gain >13 kg for underweight, normal weight or overweight mothers and > 9 kg for obese mothers

  5. First-trimester Losses [ Time Frame: 14 weeks of gestation ]
  6. Second and Third-trimester Losses [ Time Frame: 28 weeks of gestation and end of gestation ]
  7. Live-born Children [ Time Frame: End of pregnancy ]
  8. Babies Born at Term [ Time Frame: End of pregnancy ]
  9. Appropriate-for-gestational Age Babies [ Time Frame: End of pregnancy ]
  10. Neonates With Hypoglycemia [ Time Frame: One, two and fours hours after birth ]
    Hypoglycemia was defined as any blood glucose concentration ≤ 40 mg/dL.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria (any of the following):

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023137


Locations
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Brazil
Hospital Federal dos Servidores do Estado, Ministry of Health
Rio de Janeiro, RJ, Brazil, 20221-903
Sponsors and Collaborators
Hospital dos Servidores do Estado do Rio de Janeiro
Investigators
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Principal Investigator: Silvia Hoirisch-Clapauch, MD, PhD Hospital Federal dos Servidores do Estado
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Responsible Party: Silvia Hoirisch Clapauch, Principal Investigator, Hospital dos Servidores do Estado do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT03023137    
Other Study ID Numbers: HospitalSERJ
First Posted: January 18, 2017    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silvia Hoirisch Clapauch, Hospital dos Servidores do Estado do Rio de Janeiro:
prevention
carbohydrate
exercise
neonatal hypoglycemia
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications