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Идёт набор NCT06705712

Physical Activity, Fertility, and Spontaneous Abortion in Danish Couples Trying to Conceive

Без фазы С лечением Fertility Fecundability Time-to-Pregnancy Spontaneous Abortion

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive..
Кому может быть актуально
Состояния в реестре: Fertility, Fecundability, Time-to-Pregnancy, Spontaneous Abortion. Базовые параметры: 18 лет — 49 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

A Preconception Cohort Study of Physical Activity, Fertility, and Spontaneous Abortion - Including a Randomized Controlled Trial.

Обзор

Physical activity in both the preconception period and during pregnancy may enhance the probability of getting pregnant and reduce the risks of complications during pregnancy. Adults, including pregnant women without complications, are recommended to be physically active for at least 30 minutes per day to maintain physical and mental health. Nonetheless, many women reduce their level of exercise during early pregnancy. With this project, we will test the effectiveness of receiving motivational counseling on physical activity (PA) among women trying to conceive and during the first trimester of the pregnancy if they conceive. We will further investigate whether PA is associated with fecundability, spontaneous abortion (SAB) and other birth outcomes, i.e., gestational diabetes, preeclampsia, and birth weight.

Подробное описание

Infertility, defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse, and spontaneous abortion (SAB) are significant public health problems, affecting up to 20% of reproductive age couples in the Western World. A large proportion of couples seek fertility treatment, which is not only an economic burden for the society, but also associated with adverse health effects among infertile couples. The causes of both infertility and SAB are multifactorial and identification of modifiable risk factors is an important public health goal.

According to the Danish Health Authority, adults are recommended to be physically active for at least 30 minutes per day, to undertake muscle-strengthening activities on two or more days per week and to reduce sedentary time. The same applies for pregnant women without complications. However, only 15-38% of pregnant women adhere to the recommendations for PA and many women reduce their level of exercise during early pregnancy compared with pre-pregnancy. Yet, maternal health in both the preconception period and during pregnancy is critical to avoid complications during pregnancy and for the long-term health of mother and child.

We therefore aim to investigate the association between PA, fecundability (i.e., the average per-cycle probability of conception), and SAB. An efficient web-based infrastructure to recruit, follow, and collect comprehensive data has already been developed. In the ongoing prospective cohort study, SnartForældre.dk (SF), we investigate fecundability and SAB according to demographic, behavioral, environmental, and medical factors and have enrolled more than 10,000 women and 1,700 of their male partners who are trying to conceive without fertility treatment.

In the present SF sub-study, SnartForældre.dk/Aktivitet, we aim to conduct a two-armed randomized controlled trial with 500 women included, to investigate the effectiveness of receiving motivational counseling on physical activity (PA) among women trying to conceive and during the first trimester of the pregnancy if they conceive. We will further investigate whether PA is associated with fecundability, spontaneous abortion (SAB) and other birth outcomes, i.e., gestational diabetes, preeclampsia, and birth weight. As we will be able to combine self-reported data, objectively measured data on PA, and high-quality Danish registry data, we have a unique possibility to evaluate the impact of PA on fecundability and SAB, as well as other pregnancy complications and birth outcomes, in a way that is hardly possible in any other country.

The study will provide important knowledge that will be of interest for the scientific world, health professionals, and for couples who suffer from infertility or experience SABs.

Вмешательства

  • Поведенческое Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.
    All participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) which will be connected with an application, Fitrockr. Data from the devices will be linked to data from the Snartforældre-questionnaires. The participants are asked to wear the tracker 24/7 during preconception and during the first trimester of their pregnancy if they conceive within 12 months. Participants will receive information material and be asked to set goals for their PA level. To follow-up on the goal set

Первичные конечные точки

  • Physical activity [Срок оценки: From randomization to end of study or censoring event, no more than 15 months]
  • Time to pregnancy (TTP) [Срок оценки: From baseline until they report a pregnancy or a censoring event (12 cycles of follow-up, cessation of pregnancy attempt, initiation of fertility treatment, withdrawal or loss to follow-up), no more than 12 months]
  • Spontaneous abortion [Срок оценки: From reported pregnancy until spontaneous abortion or censoring event (≥22 weeks' gestation, emigration, medically induced abortion or ectopic pregnancy), no more than 22 weeks from study entry]

Критерии участия

Критерии включения

  • Female
  • 18-49 years
  • In a relationship with a male partner
  • Trying to conceive

Критерии исключения

  • Using birth control
  • Receiving fertility treatment
  • Have been trying to conceive for more than six months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Дания · 1 центр
  • Department of Clinical Epidemiology — Aarhus

Идентификаторы

NCT: NCT06705712 · 1-10-72-174-23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗