Trial Outcomes & Findings for Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight (NCT NCT02473991)

NCT ID: NCT02473991

Last Updated: 2017-08-02

Results Overview

Fetal weight (fetal weight at birth) (in grams)

• Recruitment status: COMPLETED
• Target enrollment: 395 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2017-08-02

Participant Flow

Participant milestones

Measure	Pregnant Women All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI). All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation). The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985). At the time of delivery , the birth weight (in grams), and mode of delivery was be taken. After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010).
Overall Study STARTED	395
Overall Study COMPLETED	395
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight

Baseline characteristics by cohort

Measure	Pregnant Women n=395 Participants All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI). All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation). The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985). At the time of delivery , the birth weight (in grams), and mode of delivery was be taken. After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010).
Age, Continuous	25 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	395 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
weight	78 kg STANDARD_DEVIATION 12 • n=5 Participants
Height	1.7 Meter STANDARD_DEVIATION .07 • n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Fetal weight (fetal weight at birth) (in grams)

Outcome measures

Measure

Pregnant Women n=395 Participants All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI). All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation). The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985). At the time of delivery , the birth weight (in grams), and mode of delivery was be taken. After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010).

Fetal Weight (Fetal Weight at Birth)

3243 gram Standard Deviation 402

PRIMARY outcome

Timeframe: 15-20 weeks of gestation

placental thickness measured in millimeter

Outcome measures

Measure

Pregnant Women n=395 Participants All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI). All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation). The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985). At the time of delivery , the birth weight (in grams), and mode of delivery was be taken. After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010).

Placental Thickness in Second Trimester

21.5 millimeter Standard Deviation 2.5

PRIMARY outcome

Timeframe: 30-34 weeks of pregnancy

Outcome measures

Measure

Pregnant Women n=395 Participants All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, body mass index (BMI). All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation). The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al.(1985). At the time of delivery , the birth weight (in grams), and mode of delivery was be taken. After delivery, the umbilical cord was immediately clamped at its placental insertion to prevent loss of fetal blood, the maternal surface was dried with a towel, and the membranes were carefully trimmed at the placental margin. Each placenta was weighed within 15 minutes from delivery (Azpurua et al.,2010).

Placental Thickness at 3rd Trimester

35.6 millimeter Standard Deviation 4.1

Adverse Events

Pregnant Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

prof Dr khaled ebrahim abdalla

ain shams university maternity hospital

Phone: 00201023220701

Email: drkhaled_abdallah@med.asu.edu.eg

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place