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.
ContributorsZhang Lingli1, Mu Dezhi2, Zhao Yangyu3, Li Youping4, Zhang Junhua5, Feng Lin6, Hu Yan7, Li Qiuping8, Lin Zhenlang9, Luo Biru10, Qi Hongbo11, Wang Xietong12, Wang Zilian 13, Wei Ai 3, Yan Jianying15, Yang Chuanzhong15, Yi Bin16, Ying Hao17, Zhao Rongsheng18, Zheng Jun19, Zhou Ying20, Liu Dan1, Wu Lin21, Zeng Linan1, Xiao Xue21, Li Jinhui2
1 Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China
2 Department of Pediatrics, West China Second University Hospital, Sichuan University, Chengdu, China
3 Department of Gynecology and Obstetrics, Peking University Third Hospital, Peking University, Beijing, China
4 Key Laboratory of Transplant Engineering and Immunology of The Ministry of Health, Regenerative Medicine Research Centre, The Organ Transplantation Centre, West China Hospital, Sichuan University, Chengdu 610041, China; Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, China.
5 Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China
6 Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
7 School of Nursing, Fudan University, Shanghai, China.
8 Department of Neonatology, Senior Department of Pediatrics, the Seventh Medical Center of Chinese PLA General Hospital, Beijing, China.
9 Department of Pediatrics, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.
10 Department of Nursing, West China Second University Hospital, Sichuan University, Chengdu, China
11 Department of Obstetrics and Gynaecology, Chongqing Health Center for Women and Children, Chongqing, China.
12 Department of Obstetrics and Gynecology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.
13 Department of Obstetrics and Gynecology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
14 Department of Obstetrics and Gynecology, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.
15 Department of Neonatology, Affiliated Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, China.
16 Gansu Provincial Maternity and Child-Care Hospital, Lanzhou, China
17 Department of Obstetrics, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai China.
18 Department of Pharmacy, Peking University Third Hospital, Peking University, Beijing, China
19 Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin, China.
20 Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Xiamen University , Xiamen, China.
21 Department of Gynecology and Obstetrics, West China Second University Hospital, Sichuan University, Chengdu, China
Disease Category: Pregnancy & childbirth
Disease Name: Prelabour rupture of membranes
Age Range: Unknown
Sex: Female
Nature of Intervention: Drug
- Conference participants
- Consumers (patients)
- Methodologists
- Service providers
- Statisticians
- Clinical experts
- COS for clinical trials or clinical research
- COS for practice
- 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.