OBJECTIVES: To assess the optimal mode of delivery in women with, or carriers of, bleeding disorders.
SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the Cochrane Pregnancy and Childbirth Group's Trials Register as well as trials registries and the reference lists of relevant articles and reviews. Date of last search of the Group's Trials Registers: 21 June 2021.
SELECTION CRITERIA: Randomised controlled trials and quasi-randomised controlled clinical trials investigating the optimal mode of delivery in women with, or carriers of, any type of bleeding disorder during pregnancy were eligible for the review.
DATA COLLECTION AND ANALYSIS: No trials matching the selection criteria were eligible for inclusion.
MAIN RESULTS: No trials matching the selection criteria were eligible for inclusion.
AUTHORS' CONCLUSIONS: The review did not identify any randomised controlled trials investigating the safest mode of delivery and associated maternal and foetal complications during delivery in women with, or carriers of, a bleeding disorder. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials, case studies) to decide upon the optimal mode of delivery to ensure the safety of both mother and foetus. Given the ethical considerations, the rarity of the disorders and the low incidence of both maternal and foetal complications, future randomised controlled trials to find the optimal mode of delivery in this population are unlikely to be carried out. Other high quality controlled studies (such as risk allocation designs, sequential design, and parallel cohort design) are needed to investigate the risks and benefits of natural vaginal and caesarean section in this population or extrapolation from other clinical conditions that incur a haemorrhagic risk to the baby, such as platelet alloimmunisation.
METHODS AND ANALYSIS: All observational studies, including descriptive, descriptive-analytic, case-control, and cohort studies published between 1990 and 2019, will be included in the study. Review articles, case studies, case reports, letter to editors, pilot studies, and editorial will be excluded from the study. The search will be conducted in the Cochrane Central Register, MEDLINE, Google Scholar, EMBASE, ProQuest, Scopus, WOS, and CINAHL databases. Eligible studies should assess at least one of the sexual dysfunction symptoms in pregnant women or in the first year postpartum. Quality assessment of studies will be performed by two authors independently based on the NOS checklist. This checklist is designed to assess the quality of observational studies. Data will be analyzed using Stata software ver. 11. Considering that the index investigated in the present study will be the level of sexual disorder, standard error will be calculated for each study using binomial distribution. The heterogeneity level will be investigated using Cochran's Q statistic and I2 index in a chi-square test at a significance level of 1.1. Predictable limitations of this study included a small number and unacceptable quality of studies.
DISCUSSION: This systematic review addresses the factors associated with sexual dysfunction during pregnancy and postpartum. Considering the high prevalence of sexual dysfunction among women, the treatment of this problem has been highly sought after by the World Health Organization in recent years. The results of this study can help discover new strategies by introducing factors affecting women's sexual dysfunction, thereby eliminating or diminishing these factors, and play an important role in improving the quality of life of women during pregnancy and postpartum periods.
SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018083554.