Tindal Kirstin, Cousins Fiona, Palmer Kirsten Rebecca, Ellery Stacey, Vollenhoven Beverley, Gargett Caroline E, Gordon Adrienne, Bradford Billie, Davies-Tuck Miranda
The Ritchie Centre at Hudson Institute of Medical Research, Clayton, Victoria, Australia
Obstetrics and Gynaecology, Monash University School of Clinical Sciences at Monash Health, Clayton, Victoria, Australia.
BMJ Open. 2025 Jan 22;15(1):e091813. doi: 10.1136/bmjopen-2024-091813.
Early pregnancy care involves the screening and identification of women with risk factors for adverse pregnancy outcomes, including stillbirth or preterm birth, to tailor pregnancy care and interventions accordingly. Most stillbirths and approximately two-thirds of preterm births, however, occur in the absence of evident risk factors. The majority of stillbirths occur in the preterm period, yet there are few interventions targeting this period, and progress to reduce stillbirth rates remains slow. Placental dysfunction is a major contributor to stillbirth, particularly, preterm stillbirth. Here, the endometrial environment may shed light on factors that influence placental development and the trajectory of a pregnancy. Menstrual symptoms or abnormal uterine bleeding (AUB) can indicate endometrial disorders, which are associated with infertility and adverse pregnancy outcomes. Whether AUB is associated with pregnancy outcomes in the absence of a diagnosed endometrial pathology, however, remains unknown. Limited information regarding a woman's menstrual cycle is captured in routine early pregnancy assessments, such as the last menstrual period and menstrual cycle length. Given the latent diagnosis of endometrial disorders and that up to a third of all women experience AUB during their lifetime, determining the association between menstrual characteristics and pregnancy outcomes has the potential to uncover new clinical strategies to reduce adverse pregnancy outcomes. Therefore, this study aims to understand the association between menstruation and pregnancy outcomes to identify which menstrual characteristics could provide value as a pregnancy risk assessment tool.
This is a prospective study of women aged 18-45 with a singleton pregnancy. Participants will be recruited in early pregnancy at their antenatal appointment and not have a known diagnosed endometrial pathology (endometriosis, adenomyosis, endometrial cancer or an endometrial submucosal fibroid) or have had an endometrial ablation. Participants will also be excluded if there is a planned termination of pregnancy or a termination of pregnancy for psychosocial reasons. Women will complete a menstrual history survey to capture menstrual cycle length, regularity, level of pain, heaviness of flow and other menstrual symptoms. Participants will consent to having the survey data linked with their pregnancy and birth outcome information. The primary outcome is a composite of stillbirth, spontaneous preterm birth, pre-eclampsia or fetal growth restriction. Participants will also be invited to complete an optional fetal movements survey at 28-32 and 36+ weeks' gestation, and consent for placental collection at the time of birth will be sought.
Ethics approval was obtained from Monash Health Human Research Ethics Committee (83559) on 24 April 2024. The study will be conducted in accordance with these conditions. Findings will be disseminated through peer-reviewed publications and conference presentations.
早期妊娠保健包括筛查和识别有不良妊娠结局风险因素的女性,这些因素包括死产或早产,以便据此调整妊娠保健和干预措施。然而,大多数死产以及约三分之二的早产发生在没有明显风险因素的情况下。大多数死产发生在早产阶段,但针对这一阶段的干预措施很少,降低死产率的进展仍然缓慢。胎盘功能障碍是死产的主要原因,尤其是早产死产。在此,子宫内膜环境可能会揭示影响胎盘发育和妊娠轨迹的因素。月经症状或异常子宫出血(AUB)可能表明存在子宫内膜疾病,这些疾病与不孕和不良妊娠结局有关。然而,在未诊断出子宫内膜病理的情况下,AUB是否与妊娠结局相关仍不清楚。在常规早期妊娠评估中,如末次月经和月经周期长度,关于女性月经周期的信息获取有限。鉴于子宫内膜疾病的潜在诊断以及多达三分之一的女性在其一生中会经历AUB,确定月经特征与妊娠结局之间的关联有可能揭示新的临床策略以减少不良妊娠结局。因此,本研究旨在了解月经与妊娠结局之间的关联,以确定哪些月经特征可作为妊娠风险评估工具具有价值。
这是一项针对年龄在18 - 45岁的单胎妊娠女性的前瞻性研究。参与者将在早孕产前检查时招募,且没有已知诊断的子宫内膜病理(子宫内膜异位症、子宫腺肌病、子宫内膜癌或子宫内膜黏膜下肌瘤)或未进行过子宫内膜消融术。如果有计划终止妊娠或因社会心理原因终止妊娠,参与者也将被排除。女性将完成一份月经史调查问卷,以获取月经周期长度、规律性、疼痛程度、经量和其他月经症状。参与者将同意将调查数据与她们的妊娠和分娩结局信息相链接。主要结局是死产、自发性早产、子痫前期或胎儿生长受限的综合情况。参与者还将被邀请在妊娠28 - 32周和36 +周时完成一项可选的胎动调查,并在出生时寻求同意收集胎盘。
2024年4月24日获得了莫纳什健康人类研究伦理委员会(83559)的伦理批准。该研究将按照这些条件进行。研究结果将通过同行评审出版物和会议报告进行传播。