Screening Tests to identify poor Outcomes in Pregnancy (STOP) Study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000985684
• Date of registration: 12/09/2014
• Prospective Registration: Yes
• Primary sponsor: The University of Adelaide
• Public title: Screening Tests to identify poor Outcomes in Pregnancy (STOP) Study
• Scientific title: Prospective cohort study on nulliparous women with the aim of developing screening tests to identify adverse pregnancy outcomes
• Date of first enrolment: 05/03/2015
• Target sample size: 1500
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614000985684.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Claire Roberts

• Name: Prof Claire Roberts

Key inclusion & exclusion criteria

Inclusion criteria: Women with a singleton pregnancy less than 12 weeks’ gestation attending the first antenatal clinic, their partners and babies
Exclusion criteria: Women with,

1. Multiple pregnancy
2. Major fetal anomalies
3. Known essential hypertension pre-pregnancy, whether or
not on anti hypertensive medication OR
Women who are not known to have hypertension, but have
severe hypertension (blood pressure greater than 160/110mmHg) at booking
4. Type I or II diabetes
5. Renal disease
6. Systemic lupus erythematosus and anti-phospholipid
syndrome
7. Known major uterine anomaly
8. Cervical cone biopsy
9. More than 3 miscarriages more than 3 terminations
10. Treatment with low dose aspirin, calcium greater than 1g/24h, heparin, low molecular weight heparin, antioxidants (vitamin C and E) in a trial setting


Age minimum: No limit
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Preeclampsia;Small for gestational age birth;Preterm birth;Gestational diabetes mellitus;
Preeclampsia
Small for gestational age birth
Preterm birth
Gestational diabetes mellitus

Intervention(s)

This is a prospective cohort study where women with a singleton pregnancy less than 12 weeks’ gestation attending the first antenatal clinic, their partners and babies will be recruited. The women will be monitored throughout pregnancy and pregnancy complications will be diagnosed using current international guidelines as follows.

1. Preeclampsia is defined as Systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90mmHg (Korotkoff V) on at least
2 occasions 4hours apart, after 20 weeks’ gestation, but before the onset of labour and Proteinuria greater than or equal to 300 mg/24h or spot urine protein:creatinine ratio greater than or equal to 30 mg/mmol creatinine or urine dipstick protein greater than or equal to plus 2 or any multi-system
complication of preeclampsia including

a. Haematological abnormalities consisting of thrombocytopenia (platelet count less than100 x 109/L), disseminated intravascular coagulation (DIC), haemolysis (diagnosed by features on blood film such as fragmented cells, helmet cells) and reduced haptoglobin

b. Liver disease demonstrated by increased aspartate transaminase and/or alanine transaminase greater than 45 IU/L and/or severe right upper quadrant or epigastric pain, liver rupture,

c. Neurological problems including eclampsia, imminent eclampsia (severe headache with hyperreflexia and persistent visual disturbance), cerebral haemorrhage

d. Acute renal insufficiency demonstrated by new increase in serum creatinine to greater than 100 umol/L antepartum or greater than 130 umol/L postpartum

e. Pulmonary oedema confirmed by chest x-ray

2. Small for gestational age birth defined as birthweight less than 10th percentile using

Primary Outcome(s)

Composite primary outcome of pregnancy including uncomplicated pregnancy or pregnancy complications including preeclampsia, small for gestational age birth, spontaneous preterm birth or gestational diabetes mellitus (the pregnancy complications have been defined earlier)[The period of gestation at which the complication is diagnosed for preeclampsia, spontaneous preterm birth and gestational diabets mellitus and at birth for small for gestational age birth]

Secondary Outcome(s)

Customised birthweight centile[At the time of delivery]

Birthweight[At the time of delivery]

Placental weight[At the time of delivery]

Gestational age at delivery[At the time of delivery]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

The University of Adelaide

Ethics review

Status: Approved
Approval date:
Contact:

Women’s and Children’s Health Network Human Research Ethics Committee