Yang, Shaoying
Ni, Ruoning
Lu, Yikang
Wang, Suli
Xie, Feng
Zhang, Chunyan
Lu, Liangjing
Funding for this research was provided by:
National Key Research and Development Program of China (2017YFC0909000)
Article History
Received: 15 August 2019
Accepted: 29 August 2020
First Online: 9 September 2020
Ethics approval and consent to participate
: Central ethical approval has been confirmed from the Institutional Review Board (IRB) of Shanghai Renji Hospital (ref approval no. KY-2019-056), and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained. Any protocol amendments will require IRB approval. The protocol identification number on ClinicalTrials.gov is NCT03671174. We will conduct the study following the declaration of Helsinki and obtain informed consent from each participating patient before randomization. Study participation is voluntary and can be withdrawn at any time without provision of reason. On the consent form, participants will be asked if they agree to use of their data. Participants will be asked for permission for the research team to share relevant data with authorized study team members. Participants will also be asked for permission for collecting blood samples for storage in the pre-conception period, gestational week 12, and 6 weeks after delivery.
: Not applicable.
: The authors declare that they have no competing interests.