Outpatient Management of Preterm Prelabor Rupture of Membranes

NCT05755841 | Completed DMC

• 1 other identifier: 9
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Home-care management is possible if patients are clinically stable forty-eight hours after Preterm Prelabour Rupture of the membrane with no clinical or biological signs suggestive of intrauterine infection. Several retrospective studies have highlighted the safety of such outpatient management for women with nonthreatening Preterm Prelabour Rupture of the membrane. This prospective cohort study will compare inpatient versus outpatient management of preterm Prelabour rupture of membrane regarding latency, intra-amniotic infection, birth weight, and neonatal complications at 28 to 34 weeks of gestation after 48 hours of admission to Ain-Shams University Maternity Hospital.

Conditions

Management of Preterm Prelabor Rupture of Membranes

Outcome Measures

Primary Outcomes (1)

• Latency period

  the interval between rupture of the membranes and the onset of labor.

  From the time of membrane rupture till the time of delivery

Secondary Outcomes (2)

• Intraamniotic infection

  From the time of membrane rupture till the time of delivery

• Birth weight

  First 24 hours after delivery

Study Arms (2)

1

Outpatient management of preterm prelabor rupture of membranes

Other: Outpatient management of preterm prelabor rupture of membranes

2

Inpatient management of preterm prelabor rupture of membranes

Other: Inpatient management of preterm prelabor rupture of membranes

Interventions

Outpatient management of preterm prelabor rupture of membranes OTHER

Patients who will be managed as outpatients will be discharged after 48 hours of hospitalization with the following management: * Twice weekly fetal cardiotocography. * Complete blood count once a week. * A weekly clinical and ultrasound examination.

1

Inpatient management of preterm prelabor rupture of membranes OTHER

In the Inpatient Care Policy group, the same protocol as outpatient group will be applied, but the patient will not be discharged until delivery.

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women admitted to Ain Shams University Maternity Hospital due to preterm prelabor rupture of membranes

You may qualify if:

• Gestational age 28-34 weeks as calculated from the Last Menstrual period, Ultrasound examination in early 2nd trimester at 14 weeks, or first trimetric ultrasound.
• Confirmed preterm Prelabour rupture of membranes using a Sterile Cusco speculum examination, definitive history of gush of watery discharge or ultrasound measurement of the deepest vertical pocket \<2cm.

You may not qualify if:

• Mutiple pregnancy
• Cases with congenital fetal malformations conditioning prognosis
• Preterm prelabor rupture of membranes associated with preeclampsia, Diabetes mellitus, Systemic lupus erythematosus, long term steroid therapy, Renal/hepatic impairment
• Preterm Prelabour Rupture of membrane-associated with antepartum hemorrhage or asymptomatic Placenta Previa
• Past history of classic Cesarean section

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

AinShams university maternity hospital

Cairo, Egypt

Location

Related Publications (11)

• Richardson L, Kim S, Menon R, Han A. Organ-On-Chip Technology: The Future of Feto-Maternal Interface Research? Front Physiol. 2020 Jun 30;11:715. doi: 10.3389/fphys.2020.00715. eCollection 2020.

  PMID: 32695021 BACKGROUND

• Kumar D, Moore RM, Mercer BM, Mansour JM, Redline RW, Moore JJ. The physiology of fetal membrane weakening and rupture: Insights gained from the determination of physical properties revisited. Placenta. 2016 Jun;42:59-73. doi: 10.1016/j.placenta.2016.03.015. Epub 2016 Apr 1.

  PMID: 27238715 BACKGROUND

• Mercer, B.M. (2012), I240 MANAGEMENT OF PTL/PPROM. International Journal of Gynecology & Obstetrics, 119: S221-S221

  BACKGROUND

• Souza RT, Cecatti JG. A Comprehensive Integrative Review of the Factors Associated with Spontaneous Preterm Birth, Its Prevention and Prediction, Including Metabolomic Markers. Rev Bras Ginecol Obstet. 2020 Jan;42(1):51-60. doi: 10.1055/s-0040-1701462. Epub 2020 Feb 27.

  PMID: 32107766 BACKGROUND

• Hume, Robert. (2014). The Value of Money in Eighteenth-Century England: Incomes, Prices, Buying Power-and Some Problems in Cultural Economics. Huntington Library Quarterly. 77. 373-416.

  BACKGROUND

• Schmitz T, Sentilhes L, Lorthe E, Gallot D, Madar H, Doret-Dion M, Beucher G, Charlier C, Cazanave C, Delorme P, Garabedian C, Azria E, Tessier V, Senat MV, Kayem G. Preterm premature rupture of the membranes: Guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2019 May;236:1-6. doi: 10.1016/j.ejogrb.2019.02.021. Epub 2019 Mar 2.

  PMID: 30870741 BACKGROUND

• Guckert M, Clouqueur E, Drumez E, Petit C, Houfflin-Debarge V, Subtil D, Garabedian C. Is homecare management associated with longer latency in preterm premature rupture of membranes? Arch Gynecol Obstet. 2020 Jan;301(1):61-67. doi: 10.1007/s00404-019-05363-x. Epub 2019 Nov 23.

  PMID: 31760462 BACKGROUND

• Ministry of Health. 2021. Induction of Labour in Aotearoa New Zealand: A clinical practice guideline 2019. Wellington: Ministry of Health

  BACKGROUND

• Kibel M, Asztalos E, Barrett J, Dunn MS, Tward C, Pittini A, Melamed N. Outcomes of Pregnancies Complicated by Preterm Premature Rupture of Membranes Between 20 and 24 Weeks of Gestation. Obstet Gynecol. 2016 Aug;128(2):313-320. doi: 10.1097/AOG.0000000000001530.

  PMID: 27400016 BACKGROUND

• Bouchghoul H, Kayem G, Schmitz T, Benachi A, Sentilhes L, Dussaux C, Senat MV. Outpatient versus inpatient care for preterm premature rupture of membranes before 34 weeks of gestation. Sci Rep. 2019 Mar 12;9(1):4280. doi: 10.1038/s41598-019-40585-8.

  PMID: 30862787 BACKGROUND

• Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.

  PMID: 32080050 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

EG (1)