Objectives

Illustrative example - Perinatal care trial

The main research questions to test the main hypothesis are the following:

• Does the proposed intervention decrease the frequency of episiotomies (primary outcome) and of perineal sutures (secondary outcome) in the intervention hospitals relative to the control hospitals?

• Does the proposed intervention increase the frequency of injections of oxytocin during the third stage of labor (primary outcome), and decrease the frequency of postpartum hemorrhages (secondary outcome) in the intervention hospitals relative to the control hospitals?
  

Secondary research questions are the following:

• Does the proposed intervention increase the readiness to change of birth attendants (secondary outcome) in the intervention hospitals relative to the control hospitals?
  

• Are the effects, if any, sustained 1 year after the end of the intervention?’

(CLAP Trial - go to protocol)

Illustrative example - SYTRUST trial

1. Through a pre-intervention phase, to document the current strategies for screening and treating maternal syphilis and other STDs in the antenatal clinics, and to determine their effectiveness.

2. To gain an understanding of women’s health seeking behaviours during pregnancy through an assessment of 1) awareness and understanding of syphilis and other STDs and their impact on pregnancy, and 2) reasons why women often book late for antenatal care, or do not book at all.

3. To implement in six intervention clinics, on-site syphilis testing and health promotion strategies aimed at 1) increasing awareness of the impact of STDs, particularly syphilis, on pregnancy, 2) reducing the gestational age that women book for antenatal care, 3) increasing the number of women that book for antenatal care, 4) increasing the proportion of infected women who complete a course of treatment for syphilis. 

4. To develop effective partner notification strategies within the context of antenatal care.

5. To evaluate the feasibility, accuracy, and cost-effectiveness of this strategy.

6. To implement the strategy in control clinics if the findings are positive.

7. To disseminate this data and thereby inform reproductive health policy and practice, and hence improve reproductive health status.’

(SYTRUST Trial - go to protocol)

Illustrative example - WELLINGTON trial

To test the relative effectiveness of community health workers in improving the  case detection, case-holding and cure  rates of TB in the Winelands Health District, South Africa.
 (WELLINGTON Trial - go to protocol)

Illustrative example - WHO Pre-eclampsia trial

The principal objective of the trial is to test whether increasing calcium intake among nulliparous pregnant women with low calcium diets leads to a clinically relevant reduction in the incidence of pre-eclampsia.  The higher calcium intake will be achieved by means of a daily supplement.

(WHO Multicentre Randomized Trial of Calcium Supplementation for the Prevention of Pre-eclampsia - go to protocol)

Illustrative example - ISAT trial

Primary objective

To determine whether an endovascular treatment policy of acutely ruptured intracranial aneurysms compared with a neurosurgical treatment policy, reduces the proportion of patients with a moderate or poor outcome (defined by Rankin grade 3-6) by 25% at one year.

Secondary objective

To determine whether endovascular treatment:

• is as effective as neurosurgery in preventing re-bleeding from the treated aneurysm

• results in a better quality of life than neurosurgery at one year (Euroqol measure)

• is more cost effective than neurosurgical treatment

• improves the neuropsychological outcome at one year

(some centres only)

Tertiary objective

• To examine the longer term outcome over five years with specific reference to re-bleed rates.

• To determine the long-term significance of angiographic results.

(ISAT Trial - go to protocol)