Walking and Dietary Modification for Recurrent Early Miscarriages (W&D)
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|ClinicalTrials.gov Identifier: NCT03023137|
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : April 6, 2017
Last Update Posted : April 10, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||480 participants|
|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..|
|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|
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
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.
- Take-home Baby Rate [ Time Frame: End of pregnancy ]
- Gestational Diabetes Mellitus [ Time Frame: Pregnancies reaching 24 weeks' gestation ]
- Preeclampsia [ Time Frame: Pregnancies reaching 20 weeks' gestation ]
- Mothers Who Used Heparin for Nephrotic Range Proteinuria or Placental Insufficiency [ Time Frame: End of pregnancy ]
- 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
- First-trimester Losses [ Time Frame: 14 weeks of gestation ]
- Second and Third-trimester Losses [ Time Frame: 28 weeks of gestation and end of gestation ]
- Live-born Children [ Time Frame: End of pregnancy ]
- Babies Born at Term [ Time Frame: End of pregnancy ]
- Appropriate-for-gestational Age Babies [ Time Frame: End of pregnancy ]
- Neonates With Hypoglycemia [ Time Frame: One, two and fours hours after birth ]Hypoglycemia was defined as any blood glucose concentration ≤ 40 mg/dL.
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
|Hospital Federal dos Servidores do Estado, Ministry of Health|
|Rio de Janeiro, RJ, Brazil, 20221-903|
|Principal Investigator:||Silvia Hoirisch-Clapauch, MD, PhD||Hospital Federal dos Servidores do Estado|