Oral Contraceptive Pills Versus Expectant Management for Retained Pregnancy Products

NCT03230825 | Unknown

• 1 other identifier: 0263-16
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

We speculate that the use of combined oral contraceptives may be a possible solution to promote the management of retained pregnancy products versus expectant management. By withdrawing the pill, the endometrium is expected to shed in a synchronized fashion (estrogen and progestin withdrawal bleeding and may also shed the retained products of conception and avoid a surgical procedure with its related potential complications.

Conditions

Retained Products of Conception Post Abortion

Keywords

incomplete abortion; retained products of conception; combined oral contraceptives; ultrasound

Outcome Measures

Primary Outcomes (1)

• persistent retained pregnancy products rate

  rate

  4 weeks

Study Arms (2)

Oral contraceptives

EXPERIMENTAL

Oral contraceptive agent, given for free, for 3 weeks and a follow up visit a week after treatment withdrawal.

Drug: Oral contraceptive

Expectant management

SHAM COMPARATOR

Expectant management for 3 weeks and a follow up visit a week later.

Other: Expectant management

Interventions

Oral contraceptive DRUG

Daily oral contraceptive agent for 3 weeks (FLAME, containing 0.02 mg Ethinylestradiol and 0.075 mg Gestodene)

Oral contraceptives

Expectant management OTHER

No intervention and a follow up visit a wewk later

Expectant management

Eligibility Criteria

• Age: 16 Years - 54 Years
• Gender Eligibility Details: Retaiend pregnancy products
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients going through a Misoprostol or Misoprostol/Mifepristone induced procedure after a spontaneous 1st trimester pregnancy loss or as a 1st trimester planned pregnancy termination and present retained pregnancy products by a trans-vaginal ultrasound scan.
• Patients after a surgical evacuation of pregnancy products (dilatation and curettage - D\&C) of a 1st trimester miscarriage and present retained pregnancy products by a trans-vaginal ultrasound scan.
• All retained products included are of a previously confirmed intra-uterine pregnancies.
• Asymptomatic patients or mild symptoms of bleeding (spotting).
• Presence of a measurable hyperechoic material by 2 dimensional TVUS

You may not qualify if:

• Retained products with any of the following clinical presentations : more than a mild vaginal bleeding, hemodynamic instability, signs of infection and/or abdominal pain.
• Any suspicion of a molar pregnancy.
• A known contra-indication for the use of oral contraceptives

Sponsors & Collaborators

• Meir Medical Center: lead

Related Publications (5)

• Chen BA, Creinin MD. Medical management of early pregnancy failure: efficacy. Semin Reprod Med. 2008 Sep;26(5):411-22. doi: 10.1055/s-0028-1087107. Epub 2008 Sep 29.

  PMID: 18825609 BACKGROUND

• Griebel CP, Halvorsen J, Golemon TB, Day AA. Management of spontaneous abortion. Am Fam Physician. 2005 Oct 1;72(7):1243-50.

  PMID: 16225027 BACKGROUND

• Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertil Steril. 2003 Mar;79(3):577-84. doi: 10.1016/s0015-0282(02)04694-0.

  PMID: 12620443 BACKGROUND

• Sellmyer MA, Desser TS, Maturen KE, Jeffrey RB Jr, Kamaya A. Physiologic, histologic, and imaging features of retained products of conception. Radiographics. 2013 May;33(3):781-96. doi: 10.1148/rg.333125177.

  PMID: 23674774 BACKGROUND

• Casikar I, Lu C, Oates J, Bignardi T, Alhamdan D, Condous G. The use of power Doppler colour scoring to predict successful expectant management in women with an incomplete miscarriage. Hum Reprod. 2012 Mar;27(3):669-75. doi: 10.1093/humrep/der433. Epub 2012 Jan 9.

  PMID: 22232130 BACKGROUND

MeSH Terms

Conditions

Abortion, Incomplete

Interventions

Contraceptives, Oral; Watchful Waiting

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Anat Hershko Klement, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Hershko Klement, MD

CONTACT

+972549170084; anat.klement@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysis will be performed according to group code .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Once informed consent forms are signed, the patient will be randomized (using a randomization table handled by a 3rd party) into one of 2 groups: 1. Expectant management of 3 weeks and a follow up visit a week after. 2. Oral contraceptive agent, given for free, for 3 weeks and a follow up visit a week after treatment withdrawal.

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share