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Apgar; 4-7 at 1 Minute clinical trials

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.

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NCT ID: NCT04685668 Recruiting - Clinical trials for Cesarean Section Complications

The PartoMa Project: Enabling Best Post Possible Childbirth Care in Tanzania.

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Introduction Childbirth care remains suboptimal in many low-resource settings, causing unacceptable maternal and perinatal mortality and morbidity. Realistic, context-tailored clinical support is called for to assist birth attendants in providing best possible evidence-based and respectful care. The PartoMa pilot study from Zanzibar suggested that co-created clinical practice guidelines and low-dose, high-frequency training were associated with care improvements and perinatal survival. In the present study we will modify, implement and evaluate this intervention in five urban, high-volume maternity units in Tanzania. Methods and Analysis The study design is based on a theory of change, and includes three main steps: I. A mixed-methods situational analysis will explore factors affecting care. Step II. Based on step I., the PartoMa guidelines and training will be contextually modified through discussions with birth attendants and postpartum women. III. The modified intervention will be implemented through a stepped-wedge cluster trial, with embedded qualitative and economic analyses. Women in active labour and their offspring will be followed until discharge to assess intra-hospital stillbirths, intra-facility neonatal deaths and caesarean sections without medical indications, and the incremental cost-effectiveness ratio will be measured. Central intermediate outputs include health providers' knowledge, barriers and facilitators to intervention use, and clinical performance.