Pregnancies of Uncertain Location or Viability Research

NCT02700789 | Completed

• 1 other identifier: 13008
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Study to determine the diagnostic accuracy of the double decidual sac sign to predict an intrauterine pregnancy prior to ultrasonographic visualisation of embryonic contents using modern ultrasound technology.

Conditions

Intrauterine Pregnancy; Ectopic Pregnancy

Keywords

diagnostic accuracy; double decidual sac sign; intrauterine pregnancy

Outcome Measures

Primary Outcomes (1)

• Intrauterine Pregnancy

  A viable intrauterine pregnancy is defined by ultrasonographic identification of an intrauterine gestation sac with a fetal pole of any length with demonstrable fetal heart pulsations. A non-viable intrauterine pregnancy is defined as either an empty intrauterine gestation sac with mean sac diameter greater than 25mm or an intrauterine gestation sac containing a fetal pole with crown rump length greater than 7mm with no demonstrable fetal heart pulsations or in the absence of a viable embryo, no significant increase in the growth of the gestation sac or length of the fetal pole on two ultrasound scans performed more than 7 days apart. Where women underwent surgical or medical management of miscarriage, histological confirmation of the products of conception will be obtained when possible.

  Repeat transvaginal ultrasound performed 8-16 days after the index test

Secondary Outcomes (1)

• Ectopic Pregnancy

  Repeat transvaginal ultrasound performed 8-16 days after the index test

Study Arms (1)

Pregnant women

Women with a positive urinary pregnancy test following in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI) treatment will be invited to attend for an additional transvaginal ultrasound scan at 33-34 days gestation. This will be conducted by a single investigator with experience in early pregnancy ultrasound using a Voluson E8 machine with a high frequency (5-9MHz and 9-12MHz) transvaginal probe and following standard operating procedures.

Procedure: Transvaginal ultrasound scan

Interventions

Transvaginal ultrasound scan PROCEDURE

The presence of the following structures will be recorded: an intrauterine fluid collection; the double decidual sac sign; yolk sac; and fetal pole.

Pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited prospectively from Nurture Fertility, Nottingham, United Kingdom between 1st January and 31st October 2015. All women undergoing IVF/ICSI treatment will be invited to participate in the study. no ultrasonographic evidence of an intrauterine fluid collection, or a yolk sac and/or fetal pole was clearly visible within the intrauterine fluid collection. Women were also excluded if no outcome data were available or if, following the reference standard, the final diagnosis was not known (for example resolving or persistent pregnancies of unknown location).

You may qualify if:

• Positive urinary pregnancy test performed 18 days after oocyte retrieval in a fresh treatment cycle or 13-16 days after embryo transfer in a frozen embryo replacement cycle depending on the stage of embryo development at the time of transfer

You may not qualify if:

• Negative urinary pregnancy test performed 18 days after oocyte retrieval in a fresh treatment cycle or 13-16 days after embryo transfer in a frozen embryo replacement cycle depending on the stage of embryo development at the time of transfer
• No evidence of an intrauterine fluid collection during the index test
• Evidence of a yolk sac and/or fetal pole during the index test
• Final diagnosis not known

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 7, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 7, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)