A core outcome set for clinical trials of antibiotic therapy in prelabour rupture of membranes

Prelabour rupture of membranes (PROM) refers to the rupture of membranes before the onset of labor, which complicates approximately 8% of pregnancies in term, and is responsible for one third of preterm births. PROM places both mother and child at risk of infection, therefore antibiotic therapy is recommended and many clinical studies on antibiotic therapy for PROM are conducted. However, it is hard to draw conclusions on which kind, timing, course of antibiotic would be preferred. Lack of a core outcome set (COS) is one of the key factors. Problems concerning the outcome measure on PROM are shown as follows: (1) There was no agreed and standardized outcome. For example, some studies took maternal composite outcome as the outcomes, while some took chorioamnionitis, endometritis, or delivery mode as the outcomes. (2) Outcome measures varied from one trial to another For example, maternal composite outcome was composed of a diagnosis of chorioamnionitis, endometritis, or maternal sepsis in some studies, however, it was composed of intra-amniotic infection, deep vein thrombosis, postpartum hemorrhage, et al. in some studies. In consequence, it is difficult to synthesize data from individual studies, and the practical value of clinical research was limited. So, we aim to develop a COS of antibiotic therapy in prelabour rupture of membranes.

Contributors

Lingli Zhang*, Dan Liu, Lin Wu, Linan Zeng, Chuan Zhang, Hailong Li, Qiusha Yi
*Lingli Zhang is the supervisor.
Affiliations:
1.Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China
2.Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University , Chengdu, China
3.Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education , Chengdu, China
4.Department of Obsterics, West China Second University Hospital, Sichuan University, Chengdu, China

Further Study Information

Current Stage: Ongoing
Date: September 2021 - March 2022
Funding source(s): N/A


Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Prelabour rupture of membranes

Target Population

Age Range: Unknown

Sex: Female

Nature of Intervention: Drug

Stakeholders Involved

- Conference participants
- Consumers (patients)
- Methodologists
- Service providers
- Statisticians
- Clinical experts

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Systematic review

The development of this COS will include four stages: (1) a systematic review to identify potential important outcomes; (2) a panel of experts will be invited to conduct a two to three-round Delphi survey to determine the experts’ opinions on the importance of outcomes; (3) a consensus meeting with clinicians, patients, and other key stakeholders will be conducted to finalize the items and definitions; and (4) the COS will be promoted and updated.

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