NCT05110521 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Berger BO, Strobino DM, Mehrtash H, Bohren MA, Adu-Bonsaffoh K, Leslie HH, Irinyenikan TA, Maung TM, Balde MD, Tunçalp Ö
Development of measures for assessing mistreatment of women during facility-based childbirth based on labour observations. BMJ Glob Health. 2021 Aug;5(Suppl 2). pii: e004080. doi: 10.1136/bmjgh-2020-004080.
Mbindyo PM, Blaauw D, Gilson L, English M
Developing a tool to measure health worker motivation in district hospitals in Kenya. Hum Resour Health. 2009 May 20;7:40. doi: 10.1186/1478-4491-7-40.
Tripathi V, Stanton C, Strobino D, Bartlett L
Development and Validation of an Index to Measure the Quality of Facility-Based Labor and Delivery Care Processes in Sub-Saharan Africa. PLoS One. 2015 Jun 24;10(6):e0129491. doi: 10.1371/journal.pone.0129491. eCollection 2015.

Impact of a Nurse Mentorship and Digital Health Package Intervention for Maternal and Newborn Health in Kenya: A Cluster Randomized Controlled Trial

Clinical trial NCT05110521 - References