Background: Prelabor rupture of membranes (PROM) is associated with maternal and
neonatal infections. Although guidelines suggest prophylactic antibiotics for pregnant
women with PROM, the optimal antibiotic regimen remains controversial. Synthesizing the
data from different studies is challenging due to variations in reported outcomes.
Objective: This study aimed to form the initial list of outcomes for the core outcome set
(COS) that evaluates antibiotic use in PROM by identifying all existing outcomes and
patients’ views.
Methods: Relevant studies were identified by searching PubMed, EMBASE, Cochrane
Library, Chinese National Knowledge Infrastructure, Wanfang, and VIP databases. We also
screened the references of the included studies as a supplementary search. We extracted
basic information from the articles and the outcomes. Two reviewers independently
selected the studies, extracted the data, extracted the outcomes, and grouped them
into domains. Then, semi-structured interviews based on the potential factors collected by
the systematic review were conducted at West China Second Hospital of Sichuan
University. Pregnant women who met the diagnostic criteria for PROM were enrolled.
Participants reported their concerns about the outcomes. Two researchers identified the
pregnant women’s concerns.
Results: A total of 90 studies were enrolled in this systematic review. The median
outcomes in the included studies was 7 (1–31), and 109 different unique outcomes
were identified. Pre-term PROM (PPROM) had 97 outcomes, and term PROM (TPROM)
had 70 outcomes. The classification and order of the core outcome domains of PPROM
and TPROM were consistent. The physiological domain was the most common for
PPROM and TPROM outcomes. Furthermore, 35.1 and 57.1% outcomes were only
reported once in PPROM and TPROM studies, respectively. Thirty pregnant women participated in the semi-structured interviews; 10 outcomes were extracted after
normalized, and the outcomes were reported in the systematic review. However,
studies rarely reported pregnant women’s concerns.
Conclusion: There was considerable inconsistency in outcomes selection and reporting
in studies about antibiotics in PROM. An initial core outcomes set for antibiotics in PROM
was formed.
This study aimed to form the initial list of outcomes for the core outcome set (COS) that evaluates antibiotic use in PROM by identifying all existing outcomes and
patients’ views.
Dan Liu, Lin Wu, Jiefeng Luo, Siyu Li, Yan Liu, Chuan Zhang, Linan Zeng, Qin Yu, and Lingli Zhang
Disease Category: Pregnancy & childbirth
Disease Name: Prelabour rupture of membranes
Age Range: Unknown
Sex: Female
Nature of Intervention: Drug
- Consumers (patients)
- Patient perspectives
- Systematic review of outcomes measured in trials
- Interview
- Systematic review
We conducted an electronic search of PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang, and VIP Database from inception to September 2021. Then, semi-structured interviews were conducted to obtain the opinions of patients on PRO treatment.