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Study protocol. A prospective cohort study of unselected primiparous women: the pregnancy outcome prediction study.

Pasupathy D, Dacey A, Cook E, Charnock-Jones DS, White IR, Smith GC - BMC Pregnancy Childbirth (2008)

Bottom Line: There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years.Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10-14 weeks), 20 weeks, 28 weeks and 36 weeks gestation.In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Obstetrics and Gynaecology, University of Cambridge, Cambridge, UK. dp349@cam.ac.uk

ABSTRACT

Background: There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years. However, the approach to screening for other complications of pregnancy such as intra-uterine growth restriction, pre-eclampsia and stillbirth remains largely unchanged. Randomised controlled trials of routine application of high tech screening methods to the general population have generally failed to show improvement in outcome. We have previously reviewed this and concluded it was due, in large part, to poor performance of screening tests. Here, we report a study design where the primary aim is to generate clinically useful methods to screen women to assess their risk of adverse pregnancy outcome.

Methods/design: We report the design of a prospective cohort study of unselected primiparous women recruited at the time of their first ultrasound scan. Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10-14 weeks), 20 weeks, 28 weeks and 36 weeks gestation. In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth. Data will be analysed as a prospective cohort study, a case-cohort study, and a nested case-control study.

Discussion: The study is expected to provide a resource for the identification of novel biomarkers for adverse pregnancy outcome and to evaluate the performance of biomarkers and serial ultrasonography in providing clinically useful prediction of risk.

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Related in: MedlinePlus

Schematic of placental collection at delivery.
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Related In: Results  -  Collection

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Figure 1: Schematic of placental collection at delivery.

Mentions: Pregnant women receiving antenatal care in the UK National Health Service generally carry hand held notes. Women participating in the study have their hand held notes contained in a plastic folder with the study logo to flag their participation. Moreover, a sticker is placed in the delivery unit section of the notes to flag the need for placental collection and a sheet with instructions is included in the notes. This sheet includes the number for a phone held by the on-call technician. If a woman delivers at a time when a technician is present in the hospital, the placenta is passed to the technician as soon after delivery as practicable. The placenta is sampled as described in the schematic shown in Figure 1. Details of the collection protocol for the samples to be used for histological, DNA, RNA and protein analyses are given in Table 2. If the woman delivers at a time when there is no technician present, the placenta is placed in a dedicated fridge and the samples processed the following morning. The details again are described in Table 2.


Study protocol. A prospective cohort study of unselected primiparous women: the pregnancy outcome prediction study.

Pasupathy D, Dacey A, Cook E, Charnock-Jones DS, White IR, Smith GC - BMC Pregnancy Childbirth (2008)

Schematic of placental collection at delivery.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2611961&req=5

Figure 1: Schematic of placental collection at delivery.
Mentions: Pregnant women receiving antenatal care in the UK National Health Service generally carry hand held notes. Women participating in the study have their hand held notes contained in a plastic folder with the study logo to flag their participation. Moreover, a sticker is placed in the delivery unit section of the notes to flag the need for placental collection and a sheet with instructions is included in the notes. This sheet includes the number for a phone held by the on-call technician. If a woman delivers at a time when a technician is present in the hospital, the placenta is passed to the technician as soon after delivery as practicable. The placenta is sampled as described in the schematic shown in Figure 1. Details of the collection protocol for the samples to be used for histological, DNA, RNA and protein analyses are given in Table 2. If the woman delivers at a time when there is no technician present, the placenta is placed in a dedicated fridge and the samples processed the following morning. The details again are described in Table 2.

Bottom Line: There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years.Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10-14 weeks), 20 weeks, 28 weeks and 36 weeks gestation.In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Obstetrics and Gynaecology, University of Cambridge, Cambridge, UK. dp349@cam.ac.uk

ABSTRACT

Background: There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years. However, the approach to screening for other complications of pregnancy such as intra-uterine growth restriction, pre-eclampsia and stillbirth remains largely unchanged. Randomised controlled trials of routine application of high tech screening methods to the general population have generally failed to show improvement in outcome. We have previously reviewed this and concluded it was due, in large part, to poor performance of screening tests. Here, we report a study design where the primary aim is to generate clinically useful methods to screen women to assess their risk of adverse pregnancy outcome.

Methods/design: We report the design of a prospective cohort study of unselected primiparous women recruited at the time of their first ultrasound scan. Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10-14 weeks), 20 weeks, 28 weeks and 36 weeks gestation. In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth. Data will be analysed as a prospective cohort study, a case-cohort study, and a nested case-control study.

Discussion: The study is expected to provide a resource for the identification of novel biomarkers for adverse pregnancy outcome and to evaluate the performance of biomarkers and serial ultrasonography in providing clinically useful prediction of risk.

Show MeSH
Related in: MedlinePlus